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| ID | Type | Description | Link |
|---|---|---|---|
| TP-01-013 | Other Identifier | Biostable Science & Engineering, Inc | |
| TP-01-023 | Other Identifier | Biostable Science & Engineering, Inc |
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This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D intra-annular mounting frame
Aortic Regurgitation, (also known as Aortic Insufficiency; AI), is the failure of the aortic valve to close completely during diastole which causes blood to flow from the aorta back into the left ventricle. Aortic Regurgitation (AR) is a frequent cause of both disability and death due to congestive heart failure, primarily in individuals forty or older, but can also occur in younger populations.
Traditionally management of aortic regurgitation has been by aortic valve replacement, however, as has been observed in patients who have had mitral valve repair, the option of maintaining ones native aortic valve versus a replacement, either bioprosthetic or mechanical, can have added multiple benefits. The advantage of repair is the avoidance of prosthetic valve-related complications with bioprosthetic valves over 10-15 years or the need for anticoagulation with mechanical valves and the related problems of this therapy. Therefore, potentially aortic valve repair is a good option for patients with AR or AI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAART 300 Annuloplasty Device | Experimental | Implantation of HAART 300 Annuloplasty Device for aortic valve repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAART 300 Annuloplasty Device | Device | Implantation of device for aortic valve repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Outcome Measure: Event-free Survival | Event-free survival is defined as survival free from device-related death | 1 month postprocedure |
| Primary Safety Outcome Measure: Event-free Survival | Event-free survival is defined as survival free from device-related death | 2 years postprocedure (extended follow-up) |
| Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure | Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) | 6 months postprocedure |
| Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure | Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) | 2 years postprocedure (extended follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Procedure Success | Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christof Stamm, M.D. | German Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Gasthuisberg | Leuven | B-3000 | Belgium | |||
| Institut klinicke a experimantalni mediciny |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26156945 | Derived | Mazzitelli D, Fischlein T, Rankin JS, Choi YH, Stamm C, Pfeiffer S, Pirk J, Detter C, Kroll J, Beyersdorf F, Griffin CD, Shrestha M, Nobauer C, Crooke PS, Schreiber C, Lange R. Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device. Eur J Cardiothorac Surg. 2016 Mar;49(3):987-93. doi: 10.1093/ejcts/ezv234. Epub 2015 Jul 8. | |
| 25468084 |
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| ID | Title | Description |
|---|---|---|
| FG000 | HAART 300 Annuloplasty Device | Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Study Phase (6 Months) |
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| ||||||||||||||||||
| Extended Study Phase (2 Years) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HAART 300 Annuloplasty Device | Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Primary Safety Outcome Measure: Event-free Survival | Event-free survival is defined as survival free from device-related death | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month postprocedure |
|
|
Through 6 months for 16 participant receiving the implant and through 2 years for 13 of the 16 participants in extended follow-up
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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 | HAART 300 Annuloplasty Device | Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| aortic insufficiency | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Wheeler | Biostable Science and Engineering, Inc. | 512-386-1996 | John.wheeler@biostable-s-e.com |
Not provided
| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| discharge or 14 days postprocedure, whichever comes first |
| Implant Procedure Success | Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure:
| 2 years postprocedure (extended follow-up) |
| Actuarial Freedom From Clinical Cardiovascular Events | Freedom from specified clinical cardiovascular events 1 month postprocedure:
| 1 month postprocedure |
| Actuarial Freedom From Clinical Cardiovascular Events | Freedom from specified clinical cardiovascular events 2 years postprocedure:
| 2 years postprocedure |
| Event-free Survival | Event-free survival is defined as survival free from device-related death | 6 months postprocedure |
| New York Heart Association (NYHA) Functional Capacity Classification | Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort | 6 months postprocedure |
| New York Heart Association (NYHA) Functional Capacity Classification | Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort | 2 years postprocedure (extended follow-up) |
| Peak Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline, 6 months postprocedure |
| Peak Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline, 2 years postprocedure (extended follow-up) |
| Mean Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline, 6 months postprocedure |
| Mean Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline, 2 years postprocedure (extended follow-up) |
| LV Mass - Change From Baseline | Left ventricular mass. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure |
| LV Mass - Change From Baseline | Left ventricular mass. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) |
| LVID Diastole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure |
| LVID Diastole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) |
| LVID Systole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure |
| LVID Systole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) |
| LV Diastolic Volume - Change From Baseline | Left ventricular diastolic volume. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure |
| LV Diastolic Volume - Change From Baseline | Left ventricular diastolic volume. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) |
| LV Systolic Volume - Change From Baseline | Left ventricular systolic volume. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure |
| LV Systolic Volume - Change From Baseline | Left ventricular systolic volume. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) |
| LVEF - Change From Baseline | Left ventricular ejection fraction. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure |
| LVEF - Change From Baseline | Left ventricular ejection fraction. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) |
| Cardiac Output - Change From Baseline | Stroke volume x heart rate. Transthoracic echocardiography parameter. | Baseline, 6 months postprocedure |
| Cardiac Output - Change From Baseline | Stroke volume x heart rate. Transthoracic echocardiography parameter. | Baseline, 2 years postprocedure (extended follow-up) |
| Cardiac Index - Change From Baseline | Hemodynamic parameter computed as cardiac output divided by body surface area | Baseline, 6 months postprocedure |
| Cardiac Index - Change From Baseline | Hemodynamic parameter computed as cardiac output divided by body surface area | Baseline, 2 years postprocedure (extended follow-up) |
| Prague |
| 1958/9 |
| Czechia |
| German Heart Institute | Berlin | 13353 | Germany |
| German Heart Center Munich | Munich | 80636 | Germany |
| Derived |
| Mazzitelli D, Stamm C, Rankin JS, Pfeiffer S, Fischlein T, Pirk J, Choi YH, Detter C, Kroll J, Beyersdorf F, Shrestha M, Schreiber C, Lange R. Leaflet reconstructive techniques for aortic valve repair. Ann Thorac Surg. 2014 Dec;98(6):2053-60. doi: 10.1016/j.athoracsur.2014.06.052. Epub 2014 Dec 1. |
| 24113022 | Derived | Mazzitelli D, Stamm C, Rankin JS, Nobauer C, Pirk J, Meuris B, Crooke PS, Wagner A, Beavan LA, Griffin CD, Powers D, Nasseri B, Schreiber C, Hetzer R, Lange R. Hemodynamic outcomes of geometric ring annuloplasty for aortic valve repair: a 4-center pilot trial. J Thorac Cardiovasc Surg. 2014 Jul;148(1):168-75. doi: 10.1016/j.jtcvs.2013.08.031. Epub 2013 Oct 8. |
| 23959743 | Derived | Mazzitelli D, Nobauer C, Rankin JS, Badiu CC, Dorfmeister M, Crooke PS, Wagner A, Schreiber C, Lange R. Early results of a novel technique for ring-reinforced aortic valve and root restoration. Eur J Cardiothorac Surg. 2014 Mar;45(3):426-30. doi: 10.1093/ejcts/ezt407. Epub 2013 Aug 19. |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Aortic Valvular Regurgitation | Grade assigned to degree of aortic regurgitation determined by core laboratory analysis of echocardiogram: 0=None/trace, 1+=Mild, 2+=Moderate, 3+=Moderate-to-Severe, 4+=Severe | Number | participants |
|
| NYHA Classification | New York Heart Association Functional Capacity Class I: no limitation of activity. Ordinary activity - no undue fatigue, palpitation, dyspnea, or anginal pain. Class II: slight limitation of activity. Comfortable at rest. Ordinary activity - fatigue, palpitation, dyspnea, or anginal pain. Class III: marked limitation of activity. Comfortable at rest. Less than ordinary activity - fatigue, palpitation, dyspnea, or anginal pain. Class IV: no activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. Increased discomfort upon activity. | Number | participants |
|
| Peak gradient | Echocardiographic parameter determined by core laboratory. n=14 (2 unavailable or not evaluable) | Mean | Standard Deviation | mm Hg |
|
| Mean gradient | Echocardiographic parameter determined by core laboratory. n=14 (2 unavailable or not evaluable) | Mean | Standard Deviation | mm Hg |
|
| Left ventricular (LV) mass | Left ventricular mass. Echocardiographic parameter determined by core laboratory. n=11 (5 unavailable or not evaluable) | Mean | Standard Deviation | g |
|
| Left ventricular internal dimension (LVID) diastole | Left ventricular internal dimension. Echocardiographic parameter determined by core laboratory. n=11 (5 unavailable or not evaluable) | Mean | Standard Deviation | cm |
|
| LVID systole | Left ventricular internal dimension. Echocardiographic parameter determined by core laboratory. n=7 (9 unavailable or not evaluable) | Mean | Standard Deviation | cm |
|
| LV diastolic volume | Left ventricular diastolic volume. Echocardiographic parameter determined by core laboratory. n=10 (6 unavailable or not evaluable) | Mean | Standard Deviation | ml |
|
| LV systolic volume | Left ventricular systolic volume. Echocardiographic parameter determined by core laboratory. n=10 (6 unavailable or not evaluable) | Mean | Standard Deviation | ml |
|
| Left ventricular ejection fraction (LVEF) | Left ventricular ejection fraction. Echocardiographic parameter determined by core laboratory. n=10 (6 unavailable or not evaluable) | Mean | Standard Deviation | % |
|
| Cardiac output | Echocardiographic parameter determined by core laboratory. n=9 (7 unavailable or not evaluable) | Mean | Standard Deviation | l/min |
|
| Cardiac index | Cardiac index is the cardiac output divided by body surface area. n=9 (7 unavailable or not evaluable) | Mean | Standard Deviation | l/min/m^2 |
|
|
| Primary | Primary Safety Outcome Measure: Event-free Survival | Event-free survival is defined as survival free from device-related death | Extended follow-up participants | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years postprocedure (extended follow-up) |
|
|
|
| Primary | Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure | Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) | Posted | Number | participants | 6 months postprocedure |
|
|
|
| Primary | Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure | Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+) | Posted | Number | participants | 2 years postprocedure (extended follow-up) |
|
|
|
| Secondary | Implant Procedure Success | Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure:
| Posted | Number | 95% Confidence Interval | percentage of implant procedures | discharge or 14 days postprocedure, whichever comes first |
|
|
|
| Secondary | Implant Procedure Success | Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure:
| Posted | Number | 95% Confidence Interval | percentage of implant procedures | 2 years postprocedure (extended follow-up) |
|
|
|
| Secondary | Actuarial Freedom From Clinical Cardiovascular Events | Freedom from specified clinical cardiovascular events 1 month postprocedure:
| Posted | Number | 95% Confidence Interval | percentage of implant procedures | 1 month postprocedure |
|
|
|
| Secondary | Actuarial Freedom From Clinical Cardiovascular Events | Freedom from specified clinical cardiovascular events 2 years postprocedure:
| Posted | Number | 95% Confidence Interval | percentage of implant procedures | 2 years postprocedure |
|
|
|
| Secondary | Event-free Survival | Event-free survival is defined as survival free from device-related death | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months postprocedure |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Capacity Classification | Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort | NYHA evaluation not done on 1 of 15 participants | Posted | Number | participants | 6 months postprocedure |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Capacity Classification | Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort | Posted | Number | participants | 2 years postprocedure (extended follow-up) |
|
|
|
| Secondary | Peak Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline measure not available for 1 of 15 participants. | Posted | Mean | Standard Deviation | mm Hg | Baseline, 6 months postprocedure |
|
|
|
| Secondary | Peak Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline measure not available for 1 of 11 participants. | Posted | Mean | Standard Deviation | mm Hg | Baseline, 2 years postprocedure (extended follow-up) |
|
|
|
| Secondary | Mean Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline measure not available for 1 of 15 participants. | Posted | Mean | Standard Deviation | mm Hg | Baseline, 6 months postprocedure |
|
|
|
| Secondary | Mean Gradient - Change From Baseline | Transthoracic echocardiography parameter | Baseline measure not available for 1 of 11 participants. | Posted | Mean | Standard Deviation | mm Hg | Baseline, 2 years postprocedure (extended follow-up) |
|
|
|
| Secondary | LV Mass - Change From Baseline | Left ventricular mass. Transthoracic echocardiography parameter. | Both baseline and 6-month measure available for 8 of 15 participants | Posted | Mean | Standard Deviation | g | Baseline, 6 months postprocedure |
|
|
|
| Secondary | LV Mass - Change From Baseline | Left ventricular mass. Transthoracic echocardiography parameter. | Both baseline and 2-year measure available for 6 of 11 participants. | Posted | Mean | Standard Deviation | g | Baseline, 2 years postprocedure (extended follow-up) |
|
|
|
| Secondary | LVID Diastole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Both baseline and 6-month measure available for 8 of 15 participants. | Posted | Mean | Standard Deviation | cm | Baseline, 6 months postprocedure |
|
|
|
| Secondary | LVID Diastole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Both baseline and 2-year measure available for 7 of 11 participants. | Posted | Mean | Standard Deviation | cm | Baseline, 2 years postprocedure (extended follow-up) |
|
|
|
| Secondary | LVID Systole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Both baseline and 6-month measure available for 5 of 15 participants. | Posted | Mean | Standard Deviation | cm | Baseline, 6 months postprocedure |
|
|
|
| Secondary | LVID Systole - Change From Baseline | Left ventricular internal dimension. Transthoracic echocardiography parameter. | Both baseline and 2-year measure available for 3 of 11 participants. | Posted | Mean | Standard Deviation | cm | Baseline, 2 years postprocedure (extended follow-up) |
|
|
|
| Secondary | LV Diastolic Volume - Change From Baseline | Left ventricular diastolic volume. Transthoracic echocardiography parameter. | Both baseline and 6-month measure available for 7 of 15 participants. | Posted | Mean | Standard Deviation | ml | Baseline, 6 months postprocedure |
|
|
|
| Secondary | LV Diastolic Volume - Change From Baseline | Left ventricular diastolic volume. Transthoracic echocardiography parameter. | Both baseline and 2-year measure available for 5 of 11 participants. | Posted | Mean | Standard Deviation | ml | Baseline, 2 years postprocedure (extended follow-up) |
|
|
|
| Secondary | LV Systolic Volume - Change From Baseline | Left ventricular systolic volume. Transthoracic echocardiography parameter. | Both baseline and 6-month measure available for 7 of 15 participants. | Posted | Mean | Standard Deviation | ml | Baseline, 6 months postprocedure |
|
|
|
| Secondary | LV Systolic Volume - Change From Baseline | Left ventricular systolic volume. Transthoracic echocardiography parameter. | Both baseline and 2-year measure available for 5 of 11 participants. | Posted | Mean | Standard Deviation | ml | Baseline, 2 years postprocedure (extended follow-up) |
|
|
|
| Secondary | LVEF - Change From Baseline | Left ventricular ejection fraction. Transthoracic echocardiography parameter. | Both baseline and 6-month measure available for 7 of 15 participants. | Posted | Mean | Standard Deviation | percentage of blood volume | Baseline, 6 months postprocedure |
|
|
|
| Secondary | LVEF - Change From Baseline | Left ventricular ejection fraction. Transthoracic echocardiography parameter. | Both baseline and 2-year measure available for 5 of 11 participants. | Posted | Mean | Standard Deviation | percentage of blood volume | Baseline, 2 years postprocedure (extended follow-up) |
|
|
|
| Secondary | Cardiac Output - Change From Baseline | Stroke volume x heart rate. Transthoracic echocardiography parameter. | Both baseline and 6-month measure available for 7 of 15 participants. | Posted | Mean | Standard Deviation | l/min | Baseline, 6 months postprocedure |
|
|
|
| Secondary | Cardiac Output - Change From Baseline | Stroke volume x heart rate. Transthoracic echocardiography parameter. | Both baseline and 2-year measure available for 5 of 11 participants. | Posted | Mean | Standard Deviation | l/min | Baseline, 2 years postprocedure (extended follow-up) |
|
|
|
| Secondary | Cardiac Index - Change From Baseline | Hemodynamic parameter computed as cardiac output divided by body surface area | Both baseline and 6-month measure available for 7 of 15 participants. | Posted | Mean | Standard Deviation | l/min/m^2 | Baseline, 6 months postprocedure |
|
|
|
| Secondary | Cardiac Index - Change From Baseline | Hemodynamic parameter computed as cardiac output divided by body surface area | Both baseline and 2-year measure available for 5 of 11 participants. | Posted | Mean | Standard Deviation | l/min/m^2 | Baseline, 2 years postprocedure (extended follow-up) |
|
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|
| 8 |
| 16 |
| 15 |
| 16 |
| arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| syncope | Cardiac disorders | Non-systematic Assessment |
|
| GI bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| central venous catheter infection | Infections and infestations | Non-systematic Assessment |
|
| primary coxarthrosis left | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| radial fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| choreiform movement disorder | Nervous system disorders | Non-systematic Assessment |
|
| postop delirium | Nervous system disorders | Non-systematic Assessment |
|
| urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| subcutaneous emphysema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| enhanced plasma free hemoglobin value | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| conduction defects | Cardiac disorders | Non-systematic Assessment |
|
| intramural aortic hematoma | Cardiac disorders | Non-systematic Assessment |
|
| pericardial effusion | Cardiac disorders | Non-systematic Assessment |
|
| chest pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| cicatrical hernia | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| reddening of wound | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| arthrosis left knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| hip pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| thoracal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| pulmonary mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| flickering in the eyes | Nervous system disorders | Non-systematic Assessment |
|
| numbness of left little finger | Nervous system disorders | Non-systematic Assessment |
|
| postoperative delirium | Nervous system disorders | Non-systematic Assessment |
|
| symptomatic transitory psychotic syndrome | Nervous system disorders | Non-systematic Assessment |
|
| cystitis | Renal and urinary disorders | Non-systematic Assessment |
|
| hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| dysphonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| flu with fever | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| mild cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| clavus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| thrombophlebitis | Vascular disorders | Non-systematic Assessment |
|
Publication by the investigator was not allowed until completion of the trial. All proposed publications must be cleared by unanimous vote of a publication committee consisting of the sponsor and representatives of the study investigators. Publication materials must be submitted for review at least 60 day in advance of publication. The Sponsor may embargo publication for 60 additional days to allow for patent filing or may prevent publication if filling of such application would be premature.
| Measurements |
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| 3+ |
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| 4+ |
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| Measurements |
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| 3+ |
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| 4+ |
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| Title | Measurements |
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| IV |
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| Title | Measurements |
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| IV |
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