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| Name | Class |
|---|---|
| LivaNova | INDUSTRY |
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This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.
This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant, on patients that are off anticoagulation for at least 30 days. A minimum of 75 subjects with evaluable 4D CT scans will be enrolled at approximately 11 investigational sites where the devices are commercially available. For asymptomatic subjects, PIs and subjects will be blinded from the CT imaging results and from the Core Lab findings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic Valve | Other | LivaNova bioprosthetic aortic heart valve replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4D Cardiac CT Scan | Diagnostic Test | 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Leaflet Motion | Report the overall incidence of reduced leaflet motion identified by CT imaging in commercially approved LivaNova bioprosthetic aortic heart valves up to 1 year post implant on patients that are off anticoagulation for at least 30 days. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion). | 1 year post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes | Incidence of reduced leaflet motion in symptomatic and asymptomatic subjects based on CT outcomes and anticoagulation and dual antiplatelet treatment modalities up to 1 year post-implant. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niv Ad, MD | Washington Adventist Hospital | Principal Investigator |
| Federico Asch, MD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent Cardiovascular Research Institute | Indianapolis | Indiana | 46290 | United States | ||
| Maine Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25184874 | Background | Adams DH, Popma JJ, Reardon MJ. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 Sep 4;371(10):967-8. doi: 10.1056/NEJMc1408396. No abstract available. | |
| 20961243 | Background | Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22. |
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88 subjects undergoing AVR with the commercially available Perceval S Valve (Manufacturer Livanova, now transitioned to Corcym), having signed informed consent and willing and able to undergo 4D CT assessments with contrast (or alternatively TEE) were enrolled in the study. The study was forseeing 24 month of enrollment and 1 Year follow-up. The first enrolment occured on on August 12, 2017, and the last enrollment on May 22, 2019 in a total of 10 clinical study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aortic Valve | LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aortic Valve | LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care. |
| 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 | Reduction in Leaflet Motion | Report the overall incidence of reduced leaflet motion identified by CT imaging in commercially approved LivaNova bioprosthetic aortic heart valves up to 1 year post implant on patients that are off anticoagulation for at least 30 days. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion). | Posted | Count of Participants | Participants | 1 year post-implant |
|
Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up
The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following
Other (Not Including Serious) Adverse Events were not monitored/assessed.
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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 | Aortic Valve | LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access site haematoma | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elisa Cerutti | Corcym S.r.l. | +393459182413 | elisa.cerutti@corcym.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 5, 2018 | Sep 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 14, 2019 | Sep 29, 2023 | SAP_001.pdf |
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Prospective, multi-center trial
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| LivaNova Bioprothetic Aortic Valve Implant | Device | Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care. |
|
| up to 1 year post-implant |
| Reduced Leaflet Motion Through 4D Volume-rendered CT Scan | Incidence of reduced leaflet motion through 4D volume-rendered CT scan with contrast up to 1 year post-implant, in subjects in which reduced leaflet motion was previously detected. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion). | up to 1 year post-implant |
| Reduction in Leaflet Motion by Relationship to Devices or Procedure | Incidence of reduced leaflet motion considering relationship to the devices, procedure, or other causes up to 1 year post-implant The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion). | up to 1 year post-implant |
| Freedom From All-cause Mortality | Number and incidence of subjects free from all-cause mortality | up to 1 year post-implant |
| Freedom From Valve Re-intervention | Number and incidence of subjects free from valve reintervention | up to 1 year post-implant |
| Freedom From Myocardial Infarction | Number and incidence of subjects free from myocardial infarction | up to 1 year post-implant |
| Freedom From Structural Valve Deterioration | Number and incidence of subjects free from structural valve deterioration | up to 1 year post-implant |
| Freedom From Moderate or Severe Valve Regurgitation | Number and incidence of subjects free from moderate or severe valve regurgitation | up to 1 year post-implant |
| Freedom From Valve Endocarditis | Number and incidence of subjects free from valve endocarditis | up to 1 year post-implant |
| Freedom From Valve Thrombosis | Number and incidence of subjects free from valve thrombosis | up to 1 year post-implant |
| Freedom From Thromboembolic Events | Number and incidence of subjects free from thromboembolic events | up to 1 year post-implant |
| Freedom From Hemolysis | Number and incidence of subjects free from hemolysis | up to 1 year post-implant |
| Freedom From Major Bleeding | Number and incidence of subjects free from major bleeding | up to 1 year post-implant |
| New York Heart Association (NYHA) Assessment | Number and incidence of subjects in the different NYHA class at 1 year post-implant. NYHA I = Subjects with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina. NYHA II = Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina. NYHA III = Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina. NYHA IV = Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or angina may be present even at rest. If any physical activity is undertaken, discomfort is increased. | 1 year post-implant |
| Aortic Peak Gradient Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | up to 1 year post-implant |
| Aortic Mean Gradient Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | up to 1 year post-implant |
| Effective Orifice Area Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | up to 1 year post-implant |
| Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | up to 1 year post-implant |
| Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | up to 1 year post-implant |
| Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | up to 1 year post-implant |
| Scarborough |
| Maine |
| 04074 |
| United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | United States |
| Oakwood Hospital | Dearborn | Michigan | 48124 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Missouri Baptist Hospital | St Louis | Missouri | 63131 | United States |
| Centennial | Nashville | Tennessee | 37203 | United States |
| Valley Health | Winchester | Virginia | 22601 | United States |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Universite Laval | Québec | Quebec | G1V4G5 | Canada |
| 25079769 | Background | Mohr FW, Holzhey D, Mollmann H, Beckmann A, Veit C, Figulla HR, Cremer J, Kuck KH, Lange R, Zahn R, Sack S, Schuler G, Walther T, Beyersdorf F, Bohm M, Heusch G, Funkat AK, Meinertz T, Neumann T, Papoutsis K, Schneider S, Welz A, Hamm CW; GARY Executive Board. The German Aortic Valve Registry: 1-year results from 13,680 patients with aortic valve disease. Eur J Cardiothorac Surg. 2014 Nov;46(5):808-16. doi: 10.1093/ejcts/ezu290. Epub 2014 Jul 30. |
| 26437127 | Background | Laschinger JC, Wu C, Ibrahim NG, Shuren JE. Reduced Leaflet Motion in Bioprosthetic Aortic Valves--The FDA Perspective. N Engl J Med. 2015 Nov 19;373(21):1996-8. doi: 10.1056/NEJMp1512264. Epub 2015 Oct 5. No abstract available. |
| 26436963 | Background | Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5. |
| 20329497 | Background | Beholz S, Repossini A, Livi U, Schepens M, El Gabry M, Matschke K, Trivedi U, Eckel L, Dapunt O, Zamorano JL. The Freedom SOLO valve for aortic valve replacement: clinical and hemodynamic results from a prospective multicenter trial. J Heart Valve Dis. 2010 Jan;19(1):115-23. |
| 26443880 | Background | Thalmann M, Grubitzsch H, Matschke K, Glauber M, Tan E, Francois K, Amorim MJ, Hensens AG, Cesari F, Feyrer R, Diegeler A, Veit F, Repossini A; Freedom Solo Investigators. A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis. Ann Thorac Surg. 2016 Jan;101(1):100-8. doi: 10.1016/j.athoracsur.2015.06.096. Epub 2015 Oct 9. |
| 25501554 | Background | Grubitzsch H, Wang S, Matschke K, Glauber M, Heimansohn D, Tan E, Francois K, Thalmann M. Clinical and haemodynamic outcomes in 804 patients receiving the Freedom SOLO stentless aortic valve: results from an international prospective multicentre study. Eur J Cardiothorac Surg. 2015 Mar;47(3):e97-104. doi: 10.1093/ejcts/ezu471. Epub 2014 Dec 13. |
| 24603191 | Background | Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 10;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536. Epub 2014 Mar 3. No abstract available. |
| 21639811 | Background | Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5. |
| Relocation |
|
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes | Incidence of reduced leaflet motion in symptomatic and asymptomatic subjects based on CT outcomes and anticoagulation and dual antiplatelet treatment modalities up to 1 year post-implant. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion). | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Reduced Leaflet Motion Through 4D Volume-rendered CT Scan | Incidence of reduced leaflet motion through 4D volume-rendered CT scan with contrast up to 1 year post-implant, in subjects in which reduced leaflet motion was previously detected. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion). | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Reduction in Leaflet Motion by Relationship to Devices or Procedure | Incidence of reduced leaflet motion considering relationship to the devices, procedure, or other causes up to 1 year post-implant The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion). | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Freedom From All-cause Mortality | Number and incidence of subjects free from all-cause mortality | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Freedom From Valve Re-intervention | Number and incidence of subjects free from valve reintervention | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Freedom From Myocardial Infarction | Number and incidence of subjects free from myocardial infarction | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Freedom From Structural Valve Deterioration | Number and incidence of subjects free from structural valve deterioration | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Freedom From Moderate or Severe Valve Regurgitation | Number and incidence of subjects free from moderate or severe valve regurgitation | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Freedom From Valve Endocarditis | Number and incidence of subjects free from valve endocarditis | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Freedom From Valve Thrombosis | Number and incidence of subjects free from valve thrombosis | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Freedom From Thromboembolic Events | Number and incidence of subjects free from thromboembolic events | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Freedom From Hemolysis | Number and incidence of subjects free from hemolysis | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Freedom From Major Bleeding | Number and incidence of subjects free from major bleeding | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | New York Heart Association (NYHA) Assessment | Number and incidence of subjects in the different NYHA class at 1 year post-implant. NYHA I = Subjects with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina. NYHA II = Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina. NYHA III = Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina. NYHA IV = Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or angina may be present even at rest. If any physical activity is undertaken, discomfort is increased. | Posted | Count of Participants | Participants | 1 year post-implant |
|
|
|
| Secondary | Aortic Peak Gradient Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | Posted | Mean | Standard Deviation | mmHg | up to 1 year post-implant |
|
|
|
| Secondary | Aortic Mean Gradient Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | Posted | Mean | Standard Deviation | mmHg | up to 1 year post-implant |
|
|
|
| Secondary | Effective Orifice Area Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | Posted | Mean | Standard Deviation | cm2 | up to 1 year post-implant |
|
|
|
| Secondary | Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| Secondary | Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | Posted | Count of Participants | Participants | up to 1 year post-implant |
|
|
|
| 4 |
| 88 |
| 38 |
| 88 |
| 0 |
| 0 |
| Bleeding disorders | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Blood disorders | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Arrhythmias and conduction disorders | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac arrest/cardiorespiratory arrest | Cardiac disorders | Non-systematic Assessment | leading to death |
|
| Cardiac decompensation | Cardiac disorders | Non-systematic Assessment |
|
| Heart Failure | Cardiac disorders | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
|
| Thrombosis, Valve | Cardiac disorders | Non-systematic Assessment |
|
| Gastrointestinal and hepatobiliary disorders | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chest pain, noncardiac | General disorders | Non-systematic Assessment |
|
| Bacteremia | Infections and infestations | Non-systematic Assessment |
|
| Lab Test abnormality | Investigations | Non-systematic Assessment |
|
| Injuries, Trauma, Social circumstances | Social circumstances | Non-systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Confusion, Delirium | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness / Vertigo | Nervous system disorders | Non-systematic Assessment |
|
| Numbness | Nervous system disorders | Non-systematic Assessment |
|
| Other Neurologic Disorder | Nervous system disorders | Non-systematic Assessment |
|
| Stroke (CVA) | Nervous system disorders | Non-systematic Assessment | 1 case of Stroke led to death |
|
| Syncope / loss of consciousness | Nervous system disorders | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Other renal and genitourinary disorders | Renal and urinary disorders | Non-systematic Assessment |
|
| Dyspnoea/Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | leading to death |
|
| Arterial stenosis | Vascular disorders | Non-systematic Assessment |
|
| Embolization (air, tissue, septic, device) | Vascular disorders | Non-systematic Assessment |
|
| Peripheral artery stenosis/peripheral vaso-occlusive disease/peripheral vascular disease | Vascular disorders | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | Non-systematic Assessment |
|
| Thrombosis, deep vein | Vascular disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Access site infection | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Other access site complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Other cardiac disorder | Cardiac disorders | Non-systematic Assessment |
|
| Death unknown cause | General disorders | Non-systematic Assessment |
|
| Other general system disorders | General disorders | Non-systematic Assessment |
|
| Genitourinary infections | Infections and infestations | Non-systematic Assessment |
|
| Respiratory system infections | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Skin and subcutaneous infections | Infections and infestations | Non-systematic Assessment |
|
Not provided
Not provided
| NYHA class IV |
|
| Title | Measurements |
|---|
|
| Moderate |
|
| Not evaluable |
|
| Title | Measurements |
|---|
|
| Not evaluable |
|
| Title | Measurements |
|---|
|
| Not evaluable |
|