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Procedure and device development
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To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
The ACTIVE Trial is a prospective, randomized, multicenter trial. Patients with clinically significant functional mitral regurgitation will be randomized 2:1 to receive either transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) or GDMT alone. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized - Edwards Cardioband System | Experimental | Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) |
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| Randomized - Control | Active Comparator | Guideline directed medical therapy (GDMT) |
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| Roll-In - Edwards Cardioband System | Experimental | Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards Cardioband System | Device | Transcatheter mitral valve repair with the Edwards Cardioband System |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of MR ≤ 2+ and Hierarchical Comparison of Randomized Device and Randomized Control Groups [Cardiovascular Death, Number of Heart Failure Hospitalizations, Improvement in 6 MWT Distance (in Meters) and KCCQ (Number of Points Improved)]. | Hierarchical comparison of device and control groups (for randomized groups): MR ≤ 2+ and cardiovascular death, number of heart failure hospitalizations, improvement in 6 MWT distance (in meters) and KCCQ (number of points improved). | 1 year |
| Number of Participants With Major Adverse Events (MAE) [Device Group Only] | Overall rate of device and procedure related Major Adverse Events (MAEs) through 30 days post procedure (including death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention, and access site and vascular complications requiring intervention | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Endpoints [Device Group Only] | Components will be calculated with 95% confidence intervals 1. Death 2. Stroke 3. Myocardial infarction 4. Pericardial effusion requiring drainage 5. Mitral valve reintervention 6. Access site and vascular complications requiring intervention 7. Left circumflex coronary artery injury requiring intervention 8. Need for a new permanent pacemaker | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Whisenant, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Vinod Thourani, MD | Piedmont Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Stanford University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Roll-in | Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT). This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment. |
| FG001 | Experimental: Edwards Cardioband System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| At 30 Days Follow-up |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 20, 2018 | May 26, 2022 |
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| Guideline Directed Medical Therapy | Drug | GDMT Only |
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| Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only) | The following key secondary efficacy endpoints will be tested in comparison to control in a hierarchical order to preserve statistical power. 1. MR ≤ 1+ 2. NYHA Class 3. Kansas City Cardiomyopathy Questionnaire (KCCQ) 4. 6 Minute Walk Test (6MWT) 5. SF-36v2 Health Survey (SF-36) 6. Heart Failure Hospitalizations 7. Cardiovascular mortality | 1 year |
| Device Success | Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory (per device analysis). | 30 days |
| Procedural Success | Device success with evidence of MR reduction to ≤ MR2+ at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge (per patient analysis). | 30 days |
| Clinical Success | Procedural success with evidence of MR reduction ≤ MR2+ and without MAEs* at 30 days (per patient analysis). *Major adverse events (MAE) defined as death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention and access site and vascular complications requiring intervention. | 30 days |
| Palo Alto |
| California |
| 94304 |
| United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| St. Vincent Heart Center | Indianapolis | Indiana | 46290 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Columbia University Medical Center/New York Presbyterian Hospital | New York | New York | 10032 | United States |
| Lenox Hill Hospital - Northwell Health | New York | New York | 10075 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| Sanger Heart & Vascular Institute - Atrium Health | Charlotte | North Carolina | 28203 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Providence Health &Services, Heart & Vascular Institute | Portland | Oregon | 97225 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Pinnacle Health | Harrisburg | Pennsylvania | 17101 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) |
| FG002 | Control: No Intervention | Guideline directed medical therapy (GDMT) |
| COMPLETED |
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| NOT COMPLETED |
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| At 6 Months Follow-up |
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| At 1 Year Follow-up |
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| At 2 Year Follow-up |
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| At 3 Year Follow-up |
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| At 4-year Follow-up |
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| At 5-year Follow-up |
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Data were not collected for the experimental or control group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Roll-in | Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT). This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment. |
| BG001 | Experimental: Edwards Cardioband System | Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) |
| BG002 | Control: No Intervention | Guideline directed medical therapy (GDMT) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Data unavailable for 3 patients | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| NYHA Functional Class | Measure Description: NYHA Classification - The stages of heart failure: 1. Class I - No symptoms and no limitation in ordinary physical activity 2. Class II - Mild symptoms and slight limitation during ordinary activity. 3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. 4. Class IV - Severe limitations. Experiences symptoms even while at rest | Count of Participants | Participants |
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| 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 | Prevalence of MR ≤ 2+ and Hierarchical Comparison of Randomized Device and Randomized Control Groups [Cardiovascular Death, Number of Heart Failure Hospitalizations, Improvement in 6 MWT Distance (in Meters) and KCCQ (Number of Points Improved)]. | Hierarchical comparison of device and control groups (for randomized groups): MR ≤ 2+ and cardiovascular death, number of heart failure hospitalizations, improvement in 6 MWT distance (in meters) and KCCQ (number of points improved). | No patients were randomized, therefore no data was collected. This parameter is meant to be analyzed in hierarchical order for the randomized arms only. | Posted | 1 year |
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| Primary | Number of Participants With Major Adverse Events (MAE) [Device Group Only] | Overall rate of device and procedure related Major Adverse Events (MAEs) through 30 days post procedure (including death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention, and access site and vascular complications requiring intervention | No patients were randomized, therefore no data was collected in the randomized phase. | Posted | Count of Participants | Participants | 30 days |
| |||||||||||||||||||||
| Secondary | Secondary Safety Endpoints [Device Group Only] | Components will be calculated with 95% confidence intervals 1. Death 2. Stroke 3. Myocardial infarction 4. Pericardial effusion requiring drainage 5. Mitral valve reintervention 6. Access site and vascular complications requiring intervention 7. Left circumflex coronary artery injury requiring intervention 8. Need for a new permanent pacemaker | No patients were randomized, therefore no data was collected | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only) | The following key secondary efficacy endpoints will be tested in comparison to control in a hierarchical order to preserve statistical power. 1. MR ≤ 1+ 2. NYHA Class 3. Kansas City Cardiomyopathy Questionnaire (KCCQ) 4. 6 Minute Walk Test (6MWT) 5. SF-36v2 Health Survey (SF-36) 6. Heart Failure Hospitalizations 7. Cardiovascular mortality | No patients were randomized, therefore no data was collected. The parameter is meant to be analyzed in hierarchical order for the randomized arms only. | Posted | 1 year |
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| Secondary | Device Success | Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory (per device analysis). | No patients were randomized, therefore no data was collected in the randomized phase. | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Procedural Success | Device success with evidence of MR reduction to ≤ MR2+ at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge (per patient analysis). | No patients were randomized, therefore no data was collected in the randomized phase. | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Clinical Success | Procedural success with evidence of MR reduction ≤ MR2+ and without MAEs* at 30 days (per patient analysis). *Major adverse events (MAE) defined as death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention and access site and vascular complications requiring intervention. | No patients were randomized, therefore no data was collected in the randomized phase. | Posted | Count of Participants | Participants | 30 days |
|
5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
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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 | Roll-in | Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT). This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment. | 4 | 12 | 9 | 12 | 8 | 12 |
| EG001 | Experimental: Edwards Cardioband System | Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Control: No Intervention | Guideline directed medical therapy (GDMT) | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Left Ventricular Failure | Cardiac disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrial Flutter | Cardiac disorders | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | Systematic Assessment |
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| Cardiac Failure Acute | Cardiac disorders | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | Systematic Assessment |
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| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
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| Mitral Valve Incompetence | Cardiac disorders | Systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
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| Pulmonary Oedema | Cardiac disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Clostridium Difficile Colitis | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Septic Shock | Infections and infestations | Systematic Assessment |
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| Clavicle Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Subdural Haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Device Dislocation | Product Issues | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cardiac Resynchronisation Therapy | Surgical and medical procedures | Systematic Assessment |
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| Chronic Left Ventricular Failure | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrioventricular Block First Degree | Cardiac disorders | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | Systematic Assessment |
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| Mitral Valve Incompetence | Cardiac disorders | Systematic Assessment |
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| Nodal Rhythm | Cardiac disorders | Systematic Assessment |
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| Supraventricular Extrasystoles | Cardiac disorders | Systematic Assessment |
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| Tricuspid Valve Incompetence | Cardiac disorders | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Viral Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
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| Humerus Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Medical Device Site Injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Electrocardiogram Qt Prolonged | Investigations | Systematic Assessment |
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| Troponin I Increased | Investigations | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
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| Renal Impairment | Renal and urinary disorders | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Air Embolism | Vascular disorders | Systematic Assessment |
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| Haematoma | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Bundle Branch Block Right | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ted Feldman | Edwards Lifesciences | 949-250-2500 | Feldman_Info@edwards.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2019 | May 26, 2022 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Re-attempt procedure |
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| Aborted implant |
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