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The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR). Therapeutic alternatives are open-heart cardiac surgery, and palliative medical therapy with or without device therapy. The study will observe the outcomes of patients treated with the MitraClip System throughout 12-months as compared to the outcomes of patients treated by alternative therapies.
PHASE I:
The primary objective of ACCESS-EU Phase I is to gain information in the European Union Countries regarding the use of the MitraClip System with respect to health economics and clinical care.
PHASE II: (HAS BEEN CLOSED BY SPONSOR) The primary objective of ACCESS-EU Phase II is to gather additional clinical data, specifically Echocardiography Core Laboratory measurements of MR severity and left ventricular volumes and diameters, and other echocardiographic measures, on patients undergoing the MitraClip procedure in the European Union Countries,
Clinical data collected from both study phases, is expected to contribute to decision making with regards to MitraClip therapy selection in patients with MR: (a) by establishing the value of the MitraClip therapy in the continuum of care; and (b) by providing practical information that will allow physicians to make therapeutic decisions, assist hospitals to make purchasing decisions, and assist insurers in making coverage decisions.
Study Design:
ACCESS-Europe is a two-phase prospective, observational, multicenter post-approval study of the MitraClip System for the treatment of mitral regurgitation (MR) in the European Union Countries. Patients will be evaluated per standard practice at baseline, discharge, 6-Months and 12-Months.
Phase I of the study consists of patients who receive the MitraClip system for the treatment of MR and two concurrent comparator groups of (a) medically managed heart failure patients with MR and (b) patients who have undergone mitral valve surgery for MR. The two comparator groups will be followed and evaluated primarily from a health economic perspective.
ACCESS EU Study Phase II will consist of only patients who receive the MitraClip System, with the objective to collect additional clinical data, specifically Echocardiography Core Laboratory evaluation of MR severity and other echocardiographic measures.
Enrollment of patients in each study phase is as follows:
ACCESS-EU PHASE I:
First Patient Enrollment Projection: Q1, 2009 Last Patient Enrollment Projection: Enrollment in the Mitral Valve Surgery and Medically Therapy groups ceased on December 31, 2010. Enrollment in the MitraClip group will cease when Phase II of the study is initiated at each site.
ACCESS-EU PHASE II:
A minimum of 300 MitraClip therapy subjects will be enrolled in Phase II.
First Patient Enrollment Projection: Q2, 2011 Last Patient Enrollment Projection: Enrollment will cease when the Sponsor has determined that an adequate number of patients have been enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MitraClip Therapy | Patients treated with the MitraClip System. |
| |
| Medical Management | Patients with MR managed non-surgically based on standard hospital clinical practice. |
| |
| Mitral Valve Surgery | Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MitraClip | Device | The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets |
| Measure | Description | Time Frame |
|---|---|---|
| MR Severity | MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe. MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported. | At baseline |
| MR Severity | MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe. MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at follow-up is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported. | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time | Procedure Time is defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter is removed. | Day 0 (On the day of procedure) |
| Contrast Volume |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Mitral Regurgitation
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| Name | Affiliation | Role |
|---|---|---|
| Barathi Sethuraman, PhD | Abbott Vascular Structural Heart (Evalve Inc) | Study Director |
| Wolfgang Schillinger, MD | Universitatsmedizin Gottingen | Principal Investigator |
| Francesco Maisano, MD | Fondazion Ctr San Raffaele Del Monte Tabor Istituto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitatsmedizin Gottingen | Göttingen | 37075 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19682161 | Background | Rogers JH, Yeo KK, Carroll JD, Cleveland J, Reece TB, Gillinov AM, Rodriguez L, Whitlow P, Woo YJ, Herrmann HC, Young JN. Late surgical mitral valve repair after percutaneous repair with the MitraClip system. J Card Surg. 2009 Nov-Dec;24(6):677-81. doi: 10.1111/j.1540-8191.2009.00901.x. Epub 2009 Jul 24. | |
| 19679246 | Background |
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The ACCESS-EU Phase I Study began enrolling patients in October 2, 2008 and completed enrollment on April 13, 2011. There were 567 patients enrolled at 14 investigational sites in Europe. The last follow-up visit occurred on June 15, 2012 and the last monitoring visit occurred August 9, 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | MitraClip Therapy | Patients treated with the MitraClip System. MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets |
| FG001 | Medical Management | Patients with MR managed nonsurgically based on standard hospital clinical practice. Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included. |
| FG002 | Mitral Valve Surgery | Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MitraClip Therapy | Patients treated with the MitraClip System. MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets |
| BG001 | Medical Management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MR Severity | MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe. MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported. | MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. MR severity will not be reported for these comparator arms. A total of 240 patients excluded from analysis population due to death:98, withdrew consent:58, lost to follow-up:22 and missed mitral regurgitation evaluation:62 at baseline. | Posted | Number | percentage of participants | At baseline |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MitraClip Therapy | Patients treated with the MitraClip System. MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Septal Defect (ASD) | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Septal Defect (ASD) | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey T Ellis | Abbott Vascular | jeffrey.ellis@av.abbott.com |
Not provided
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D020399 | Practice Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Medical Management | Drug | The Non-Surgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed non-surgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included |
|
| Mitral Valve Surgery | Procedure | The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded. |
|
| Day 0 (On the day of procedure) |
| Fluoroscopy Duration | Day 0 (On the day of procedure) |
| Number of MitraClip Devices Implanted | Physicians had the option of deploying more than 1 MitraClip device if a single device did not provide satisfactory MR reduction, and if the mitral valve area was large enough to allow multiple MitraClip devices to be placed without causing mitral stenosis. | Day 0 (On the day of procedure) |
| ICU and Hospital Stay | ICU and hospital stay is defined as the mean duration of time that patients spent in the ICU (Intensive Care Unit)/ CCU (Cardiac Care Unit)/ PACU (Post-Anesthesia Care Unit) following the MitraClip procedure. This secondary outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. | From the day of procedure throughout 12 months of study period |
| Discharge Status and Facility | At discharge, an average of 7.7 days following the MitraClip procedure |
| Discharge MR Severity | At discharge, an average of 7.7 days following the MitraClip procedure |
| Kaplan-Meier Freedom From All-Cause Mortality | At 0 day |
| Kaplan-Meier Freedom From All-Cause Mortality | At 30 days |
| Kaplan-Meier Freedom From All-Cause Mortality | At 6 months |
| Kaplan-Meier Freedom From All-Cause Mortality | At 12 months |
| Device Embolization and Single Leaflet Device Attachment | Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets. Single leaflet device attachment (SLDA) is defined as the loss of insertion of a single leaflet from the MitraClip device with ongoing insertion of the opposing leaflet. SLDAs are reported on ACCESS-EU adverse event log and MitraClip procedure electronic case report forms, and may also be reported by Abbott Vascular personnel per EU Vigilance requirements. | Through 12 months |
| 1-Day Post-Procedure Safety Outcomes | This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. Because the Medical Therapy&Mitral Valve Surgery comparator groups were followed&studied primarily from a health economic perspective.Availability of clinical outcomes at follow-up is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported. | On day 1 post procedure |
| Need for Mitral Valve Surgery | This end point is assessed on subjects who underwent mitral valve surgery within 12 months post-MitraClip procedure. | Through 12 months |
| NYHA Functional Class | New York Heart Association (NYHA) Functional Classification. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest.Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.Less than ordinary physical activity causes fatigue, palpitation dyspnea or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest.If any physical activity is undertaken,discomfort is increased. | At baseline |
| NYHA Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity.Patients are comfortable at rest.Ordinary physical activity results in fatigue, palpitation, dyspnea/anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity.They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea/anginal pain Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken,discomfort is increased. | At 12 month |
| The Change in 6 Minute Walk Test Distance From Baseline to 12 Months | The 6 minute walk distance test will be used to measure the patient's exercise capacity. The change in 6 minute walk test distance is calculated as the difference between the distance walked at 12 months and the distanced walked at baseline. | Baseline and 12 months |
| Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months | The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL. The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40). | 12 months |
| Six Minute Walk Test Distance (6MWT) | The 6-minute walk distance test will be used to measure the patient's exercise capacity. | Baseline |
| Six Minute Walk Test Distance (6MWT) | The 6-minute walk distance test will be used to measure the patient's exercise capacity. | 12 months |
| Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D; EVEREST Investigators. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. 2009 Aug 18;54(8):686-94. doi: 10.1016/j.jacc.2009.03.077. |
| 19284064 | Background | Herrmann HC, Kar S, Siegel R, Fail P, Loghin C, Lim S, Hahn R, Rogers JH, Bommer WJ, Wang A, Berke A, Lerakis S, Kramer P, Wong SC, Foster E, Glower D, Feldman T; EVEREST Investigators. Effect of percutaneous mitral repair with the MitraClip device on mitral valve area and gradient. EuroIntervention. 2009 Jan;4(4):437-42. doi: 10.4244/eijv4i4a76. |
| 18703359 | Background | Luk A, Butany J, Ahn E, Fann JI, St Goar F, Thornton T, McDermott L, Madayag C, Komtebedde J. Mitral repair with the Evalve MitraClip device: histopathologic findings in the porcine model. Cardiovasc Pathol. 2009 Sep-Oct;18(5):279-85. doi: 10.1016/j.carpath.2008.07.001. Epub 2008 Aug 13. |
| 17570634 | Background | Silvestry FE, Rodriguez LL, Herrmann HC, Rohatgi S, Weiss SJ, Stewart WJ, Homma S, Goyal N, Pulerwitz T, Zunamon A, Hamilton A, Merlino J, Martin R, Krabill K, Block PC, Whitlow P, Tuzcu EM, Kapadia S, Gray WA, Reisman M, Wasserman H, Schwartz A, Foster E, Feldman T, Wiegers SE. Echocardiographic guidance and assessment of percutaneous repair for mitral regurgitation with the Evalve MitraClip: lessons learned from EVEREST I. J Am Soc Echocardiogr. 2007 Oct;20(10):1131-40. doi: 10.1016/j.echo.2007.02.003. Epub 2007 Jun 13. |
| 21036802 | Background | Borgia F, Di Mario C, Franzen O. Adenosine-induced asystole to facilitate MitraClip placement in a patient with adverse mitral valve morphology. Heart. 2011 May;97(10):864. doi: 10.1136/hrt.2010.208132. Epub 2010 Oct 29. No abstract available. |
| 20948505 | Background | Tamburino C, Imme S, Barbanti M, Mule M, Pistritto AM, Aruta P, Cammalleri V, Scarabelli M, Mangiafico S, Scandura S, Ussia GP. Reduction of mitral valve regurgitation with Mitraclip(R) percutaneous system. Minerva Cardioangiol. 2010 Oct;58(5):589-98. |
| 20876188 | Background | Ciobanu A, Bennett S, Azam M, Clark A, Vinereanu D. Incremental value of three-dimensional transoesophageal echocardiography for guiding double percutaneous MitraClip (R) implantation in a 'no option' patient. Eur J Echocardiogr. 2011 Feb;12(2):E11. doi: 10.1093/ejechocard/jeq118. Epub 2010 Sep 27. |
| 20839359 | Background | Lim DS, Kunjummen BJ, Smalling R. Mitral valve repair with the MitraClip device after prior surgical mitral annuloplasty. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):455-9. doi: 10.1002/ccd.22547. |
| 20806217 | Background | Kalarus Z, Kukulski T, Lekston A, Streb W, Sikora J, Nadziakiewicz P, Gasior M, Polonski L, Zembala M. [Methodology and safety of transvascular reduction of severe ischaemic mitral insufficiency with MitraClip in high-surgical-risk patients - first three cases in Poland]. Kardiol Pol. 2010 Jun;68(6):729-35. Polish. |
| 20609795 | Background | Geidel S, Ostermeyer J, Lass M, Schmoeckel M. Complex surgical valve repair after failed percutaneous mitral intervention using the MitraClip device. Ann Thorac Surg. 2010 Jul;90(1):277-9. doi: 10.1016/j.athoracsur.2009.12.048. |
| 20598968 | Background | Mauri L, Garg P, Massaro JM, Foster E, Glower D, Mehoudar P, Powell F, Komtebedde J, McDermott E, Feldman T. The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. Am Heart J. 2010 Jul;160(1):23-9. doi: 10.1016/j.ahj.2010.04.009. |
| 20583881 | Background | Jonsson A, Settergren M. MitraClip catheter-based mitral valve repair system. Expert Rev Med Devices. 2010 Jul;7(4):439-47. doi: 10.1586/erd.10.23. |
| 20336809 | Background | Ussia GP, Barbanti M, Tamburino C. Feasibility of percutaneous transcatheter mitral valve repair with the MitraClip system using conscious sedation. Catheter Cardiovasc Interv. 2010 Jun 1;75(7):1137-40. doi: 10.1002/ccd.22415. |
| 20299349 | Background | Tamburino C, Ussia GP, Maisano F, Capodanno D, La Canna G, Scandura S, Colombo A, Giacomini A, Michev I, Mangiafico S, Cammalleri V, Barbanti M, Alfieri O. Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J. 2010 Jun;31(11):1382-9. doi: 10.1093/eurheartj/ehq051. Epub 2010 Mar 18. |
| 20219746 | Background | Franzen O, Baldus S, Rudolph V, Meyer S, Knap M, Koschyk D, Treede H, Barmeyer A, Schofer J, Costard-Jackle A, Schluter M, Reichenspurner H, Meinertz T. Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: emphasis on adverse valve morphology and severe left ventricular dysfunction. Eur Heart J. 2010 Jun;31(11):1373-81. doi: 10.1093/eurheartj/ehq050. Epub 2010 Mar 10. |
| 20103209 | Background | Argenziano M, Skipper E, Heimansohn D, Letsou GV, Woo YJ, Kron I, Alexander J, Cleveland J, Kong B, Davidson M, Vassiliades T, Krieger K, Sako E, Tibi P, Galloway A, Foster E, Feldman T, Glower D; EVEREST Investigators. Surgical revision after percutaneous mitral repair with the MitraClip device. Ann Thorac Surg. 2010 Jan;89(1):72-80; discussion p 80. doi: 10.1016/j.athoracsur.2009.08.063. |
| 23747789 | Result | Maisano F, Franzen O, Baldus S, Schafer U, Hausleiter J, Butter C, Ussia GP, Sievert H, Richardt G, Widder JD, Moccetti T, Schillinger W. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol. 2013 Sep 17;62(12):1052-1061. doi: 10.1016/j.jacc.2013.02.094. Epub 2013 Jun 7. |
| 22322574 | Result | Ussia GP, Cammalleri V, Scandura S, Imme S, Pistritto AM, Ministeri M, Chiaranda M, Caggegi A, Barbanti M, Aruta P, Tamburino C. Update on percutaneous mitral valve therapy: clinical results and real life experience. Minerva Cardioangiol. 2012 Feb;60(1):57-70. |
| 21983306 | Result | Maisano F, Godino C, Giacomini A, Denti P, Buzzatti N, Arendar I, Colombo A, Alfieri O, La Canna G. Patient selection for MitraClip therapy impaired left ventricular systolic function. Minerva Cardioangiol. 2011 Oct;59(5):455-71. |
| 24831647 | Derived | Blazek S, Lurz P, Mangner N, Fuernau G, Seeburger J, Luecke C, Gutberlet M, Ender J, Desch S, Eitel I, Schuler G, Thiele H. Incidence, characteristics and functional implications of cerebral embolic lesions after the MitraClip procedure. EuroIntervention. 2015 Feb;10(10):1195-203. doi: 10.4244/EIJY14M05_10. |
| Data unavailable |
|
Patients with MR managed nonsurgically based on standard hospital clinical practice. Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included. |
| BG002 | Mitral Valve Surgery | Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | MitraClip Therapy | Patients treated with the MitraClip System. MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets |
|
|
| Primary | MR Severity | MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe. MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at follow-up is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported. | MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. MR severity will not be reported for these comparator arms. A total of 240 patients excluded from analysis population due to death:98, withdrew consent:58, lost to follow-up:22 and missed mitral regurgitation evaluation:62 at 12 months. | Posted | Number | percentage of participants | At 12 months |
|
|
|
| Secondary | Procedure Time | Procedure Time is defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter is removed. | Procedure time is reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. Procedure Time was not recorded for 196 of 567 patients.Therefore, the data is available for 371 patients. | Posted | Mean | Standard Deviation | Minutes | Day 0 (On the day of procedure) |
|
|
|
| Secondary | Contrast Volume | Contrast volume is reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. Contrast volume was not recorded for 9 of 567 patients. Therefore, Contrast volume is available for 558 subjects. | Posted | Mean | Standard Deviation | milliliter | Day 0 (On the day of procedure) |
|
|
|
| Secondary | Fluoroscopy Duration | Fluoroscopy duration is reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups Fluoroscopy duration was not recorded for 99 of 567 patients. Therefore, Fluoroscopy duration is available for 468 patients | Posted | Mean | Standard Deviation | Minutes | Day 0 (On the day of procedure) |
|
|
|
| Secondary | Number of MitraClip Devices Implanted | Physicians had the option of deploying more than 1 MitraClip device if a single device did not provide satisfactory MR reduction, and if the mitral valve area was large enough to allow multiple MitraClip devices to be placed without causing mitral stenosis. | Number of MitraClip Devices Implanted is reported only for patients who underwent the MitraClip procedure.The Medical Therapy&Mitral Valve Surgery comparator groups were followed&studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported. | Posted | Number | percentage of participants | Day 0 (On the day of procedure) |
|
|
|
| Secondary | ICU and Hospital Stay | ICU and hospital stay is defined as the mean duration of time that patients spent in the ICU (Intensive Care Unit)/ CCU (Cardiac Care Unit)/ PACU (Post-Anesthesia Care Unit) following the MitraClip procedure. This secondary outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. | ICU and Hospital Stay is reported only for patients who underwent the MitraClip procedure.The Medical Therapy&Mitral Valve Surgery comparator groups were followed&studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported. | Posted | Mean | Standard Deviation | Days | From the day of procedure throughout 12 months of study period |
|
|
|
| Secondary | Discharge Status and Facility | Discharge Status and Facility is reported only for patients who underwent the MitraClip procedure. This secondary outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.Discharge Status and Facility outcomes data is available for 563 patients. | Posted | Number | percentage of participants | At discharge, an average of 7.7 days following the MitraClip procedure |
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| Secondary | Discharge MR Severity | MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups.MR severity will not be reported for these comparator arms. A total of 521 MitraClip patients analyzed.Missing data is due to death(n=11),patient withdrawal(n=13),data unavailable(n=3),discharge echocardiogram not done/missing(n=19). | Posted | Number | percentage of participants | At discharge, an average of 7.7 days following the MitraClip procedure |
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|
| Secondary | Kaplan-Meier Freedom From All-Cause Mortality | Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed&studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported. | Posted | Number | percentage of participants | At 0 day |
|
|
|
| Secondary | Kaplan-Meier Freedom From All-Cause Mortality | Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed & studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported. | Posted | Number | 95% Confidence Interval | percentage of participants | At 30 days |
|
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|
| Secondary | Kaplan-Meier Freedom From All-Cause Mortality | Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed & studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported. | Posted | Number | 95% Confidence Interval | percentage of participants | At 6 months |
|
|
|
| Secondary | Kaplan-Meier Freedom From All-Cause Mortality | Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed & studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported. | Posted | Number | 95% Confidence Interval | percentage of participants | At 12 months |
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|
| Secondary | Device Embolization and Single Leaflet Device Attachment | Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets. Single leaflet device attachment (SLDA) is defined as the loss of insertion of a single leaflet from the MitraClip device with ongoing insertion of the opposing leaflet. SLDAs are reported on ACCESS-EU adverse event log and MitraClip procedure electronic case report forms, and may also be reported by Abbott Vascular personnel per EU Vigilance requirements. | Device Embolization and Single Leaflet Device Attachment are reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. | Posted | Number | participants | Through 12 months |
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|
|
| Secondary | 1-Day Post-Procedure Safety Outcomes | This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. Because the Medical Therapy&Mitral Valve Surgery comparator groups were followed&studied primarily from a health economic perspective.Availability of clinical outcomes at follow-up is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported. | 1-Day Post-Procedure Safety Outcomes are reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups | Posted | Number | percentage of participants | On day 1 post procedure |
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| Secondary | Need for Mitral Valve Surgery | This end point is assessed on subjects who underwent mitral valve surgery within 12 months post-MitraClip procedure. | This outcome measure is reported only for the MitraClip device group. The need for mitral valve surgery was not captured in the Medical Management or the Mitral Valve Surgery groups. | Posted | Number | percentage of participants | Through 12 months |
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| Secondary | NYHA Functional Class | New York Heart Association (NYHA) Functional Classification. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest.Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.Less than ordinary physical activity causes fatigue, palpitation dyspnea or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest.If any physical activity is undertaken,discomfort is increased. | NYHA Functional Class was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.NYHA Functional Class will not be reported for these comparator arms.A total of 567 MitraClip patients,343 analyzed due to death:98,withdrew consent:58,lost to follow-up:22,patients had missing NYHA Functional Class assessment:46 . | Posted | Number | percentage of participants | At baseline |
|
|
|
| Secondary | NYHA Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity.Patients are comfortable at rest.Ordinary physical activity results in fatigue, palpitation, dyspnea/anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity.They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea/anginal pain Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken,discomfort is increased. | NYHA Functional Class was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.NYHA Functional Class will not be reported for these comparator arms.Of total 567 MitraClip patients,343 analyzed due to death:98,withdrew consent:58,lost to follow-up:22,patients had missing NYHA Functional Class assessment:46 . | Posted | Number | percentage of participants | At 12 month |
|
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|
| Secondary | The Change in 6 Minute Walk Test Distance From Baseline to 12 Months | The 6 minute walk distance test will be used to measure the patient's exercise capacity. The change in 6 minute walk test distance is calculated as the difference between the distance walked at 12 months and the distanced walked at baseline. | The 6-minute walk test was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.Thus it will not be reported for these comparator arms.Of the 567 MitraClip device patients,216 analyzed due to death:98,withdrew consent:58,lost to follow-up:22&173 patients did not perform the 6-minute walk test. . | Posted | Mean | Standard Deviation | meters | Baseline and 12 months |
|
|
|
| Secondary | Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months | The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL. The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40). | The MLWHF Questionnaire was not consistently administered to patients in the Medical Management&Mitral Valve Surgery groups.Thus MLWHF will not be reported for these comparator arms.Of the 567 MitraClip device patients,264 analyzed due to death:98,withdrew consent:58,lost to follow-up:22&125 patients did not complete MLWHF Questionnaire. | Posted | Mean | Standard Deviation | Quality of Life Score | 12 months |
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|
|
| Secondary | Six Minute Walk Test Distance (6MWT) | The 6-minute walk distance test will be used to measure the patient's exercise capacity. | The 6-minute walk test was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.Thus it will not be reported for these comparator arms.Of the 567 MitraClip device patients,216 analyzed due to death:98,withdrew consent:58,lost to follow-up:22&173 patients did not perform the 6-minute walk test at baseline. . | Posted | Mean | Standard Deviation | meters | Baseline |
|
|
|
| Secondary | Six Minute Walk Test Distance (6MWT) | The 6-minute walk distance test will be used to measure the patient's exercise capacity. | The 6-MWT was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.Thus it will not be reported for these comparator arms.Of the 567 MitraClip device patients,216 analyzed due to death:98,withdrew consent:58,lost to follow-up:22&173 patients did not perform the 6-minute walk test at the12 month visit. . | Posted | Mean | Standard Deviation | meters | 12 months |
|
|
|
| 13 |
| 567 |
| 371 |
| 567 |
| 367 |
| 567 |
| EG001 | Medical Management | Patients with MR managed nonsurgically based on standard hospital clinical practice. Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included. | 1 | 49 | 21 | 49 | 20 | 49 |
| EG002 | Mitral Valve Surgery | Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded. | 2 | 105 | 58 | 105 | 56 | 105 |
| Arteriovenous (AV) fistula Fistula | Cardiac disorders | Systematic Assessment |
|
| Atrioventricular block (AV block) | Cardiac disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Angina | Cardiac disorders | Systematic Assessment |
|
| Aortic Valve | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia, Other | Cardiac disorders | Systematic Assessment |
|
| Arrhythmias | Cardiac disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Atrial arrhythmias | Cardiac disorders | Systematic Assessment |
|
| Bacteremia/Septicemea | Infections and infestations | Systematic Assessment |
|
| Bleeding complications | Vascular disorders | Systematic Assessment |
|
| Blood pressure complications | Vascular disorders | Systematic Assessment |
|
| Bone and Joint Injuries | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Breathing abnormalities | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bronchial and Lung disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bruise/Contusion/Ecchymosis | Vascular disorders | Systematic Assessment |
|
| Coronary artery disease (CAD) | Cardiac disorders | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease (COPD) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cardiac Tamponade | Cardiac disorders | Systematic Assessment |
|
| Cardiac: Other | Cardiac disorders | Systematic Assessment |
|
| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
|
| Cerebro-vascular : Other | Nervous system disorders | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | Systematic Assessment |
|
| Coagulopathology | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cough (non-productive) | General disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Device complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Edema | Vascular disorders | Systematic Assessment |
|
| Endocarditis | Cardiac disorders | Systematic Assessment |
|
| Epidermal and dermal conditions | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Epistaxis | General disorders | Systematic Assessment |
|
| Esophageal injury | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Eye disorders | Eye disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Gastrointestinal (GI) hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal (GI) Infection | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal (GI) : Other | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal motility | Gastrointestinal disorders | Systematic Assessment |
|
| Generalized pain | General disorders | Systematic Assessment |
|
| Generalized weakness/fatigue | General disorders | Systematic Assessment |
|
| Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Hematologic Miscellaneous | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hematoma: Other | Vascular disorders | Systematic Assessment |
|
| Hemolysis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hemoptysis | General disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypervolemia | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Hypovolemia | Vascular disorders | Systematic Assessment |
|
| Infections | Infections and infestations | Systematic Assessment |
|
| Mental disorders | Psychiatric disorders | Systematic Assessment |
|
| Metabolic/Endocrine disorders | Metabolism and nutrition disorders | Systematic Assessment |
|
| Miscellaneous | General disorders | Systematic Assessment |
|
| Mitral Valve | Cardiac disorders | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Miscellaneous:other | General disorders | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pseudoaneurysm | Vascular disorders | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Renal: Other | Renal and urinary disorders | Systematic Assessment |
|
| Renal/Urinary Infection | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Retroperitoneal hematoma | Gastrointestinal disorders | Systematic Assessment |
|
| Skin infections | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Stroke (ischemic or hemorrhagic) | Vascular disorders | Systematic Assessment |
|
| Syncope and dizziness | General disorders | Systematic Assessment |
|
| Transient ischemic attack (TIA) | Nervous system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombosis | Vascular disorders | Systematic Assessment |
|
| Tricuspid Valve | Cardiac disorders | Systematic Assessment |
|
| Urinary Miscellaneous | Renal and urinary disorders | Systematic Assessment |
|
| Vascular : other | Vascular disorders | Systematic Assessment |
|
| Ventricular arrhythmias | Cardiac disorders | Systematic Assessment |
|
| Lower respiratory disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Arteriovenous (AV) fistula Fistula | Cardiac disorders | Systematic Assessment |
|
| Atrioventricular block (AV block) | Cardiac disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Angina | Cardiac disorders | Systematic Assessment |
|
| Aortic Valve | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia, Other | Cardiac disorders | Systematic Assessment |
|
| Arrhythmias | Cardiac disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Atrial arrhythmias | Cardiac disorders | Systematic Assessment |
|
| Bacteremia/Septicemea | Infections and infestations | Systematic Assessment |
|
| Bleeding complications | Vascular disorders | Systematic Assessment |
|
| Blood pressure complications | Vascular disorders | Systematic Assessment |
|
| Bone and Joint Injuries | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Breathing abnormalities | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bronchial and Lung disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bruise/Contusion/Ecchymosis | Vascular disorders | Systematic Assessment |
|
| Coronary artery disease (CAD) | Cardiac disorders | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease (COPD) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cardiac Tamponade | Cardiac disorders | Systematic Assessment |
|
| Cardiac: Other | Cardiac disorders | Systematic Assessment |
|
| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
|
| Cerebrovascular : Other | Nervous system disorders | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | Systematic Assessment |
|
| Coagulopathology | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cough (non-productive) | General disorders | Systematic Assessment |
|
| Device complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Edema | Vascular disorders | Systematic Assessment |
|
| Endocarditis | Cardiac disorders | Systematic Assessment |
|
| Epidermal and dermal conditions | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Epistaxis | General disorders | Systematic Assessment |
|
| Esophageal injury | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Eye disorders | Eye disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Gastrointestinal (GI) hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal (GI) Infection | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal (GI) : Other | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal motility | Gastrointestinal disorders | Systematic Assessment |
|
| Generalized pain | General disorders | Systematic Assessment |
|
| Generalized weakness/fatigue | General disorders | Systematic Assessment |
|
| Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Hematologic Miscellaneous | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hematoma: Other | Vascular disorders | Systematic Assessment |
|
| Hemolysis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hemoptysis | General disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypervolemia | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Hypovolemia | Vascular disorders | Systematic Assessment |
|
| Infections | Infections and infestations | Systematic Assessment |
|
| Mental disorders | Psychiatric disorders | Systematic Assessment |
|
| Metabolic/Endocrine disorders | Metabolism and nutrition disorders | Systematic Assessment |
|
| Miscellaneous | General disorders | Systematic Assessment |
|
| Mitral Valve | Cardiac disorders | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Miscellaneous : other | General disorders | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pseudoaneurysm | Vascular disorders | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Renal: Other | Renal and urinary disorders | Systematic Assessment |
|
| Renal/Urinary Infection | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Retroperitoneal hematoma | Gastrointestinal disorders | Systematic Assessment |
|
| Skin infections | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Stroke (ischemic or hemorrhagic) | Vascular disorders | Systematic Assessment |
|
| Syncope and dizziness | General disorders | Systematic Assessment |
|
| Transient ischemic attack (TIA) | Cardiac disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombosis | Vascular disorders | Systematic Assessment |
|
| Tricuspid Valve | Cardiac disorders | Systematic Assessment |
|
| Urinary Miscellaneous | Renal and urinary disorders | Systematic Assessment |
|
| Vascular : other† | Vascular disorders | Systematic Assessment |
|
| Ventricular arrhythmias | Cardiac disorders | Systematic Assessment |
|
| Lower respiratory disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
| D004066 | Digestive System Diseases |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|---|
|
| 2+: Moderate |
|
| 2+ to 3+: Moderate to Moderate-to-Severe |
|
| 3+: Moderate-to-Severe |
|
| 3+ to 4+: Moderate-to-Severe to Severe |
|
| 4+: Severe |
|
| Title | Measurements |
|---|---|
|
| 3 MitraClip Devices |
|
| 4 MitraClip Devices |
|
| Title | Measurements |
|---|---|
|
| Skilled nursing facility/ Hospital |
|
| Nursing home |
|
| Title | Measurements |
|---|---|
|
| 2+:Moderate |
|
| 2+ to 3+:Moderate to Moderate-to-Severe |
|
| 3+:Moderate-to-Severe |
|
| 3+ to 4+:Moderate-to-Severe to Severe |
|
| 4+:Severe |
|
| Title | Measurements |
|---|---|
|
| Respiratory Failure |
|
| Need for Resuscitation |
|
| Cardiac Tamponade |
|
| Mitral Valve Surgery |
|
| Title | Measurements |
|---|
|
| NYHA IV |
|
| Title | Measurements |
|---|
|
| NYHA IV |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|