Trial Outcomes & Findings for Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE) (NCT NCT03016975)
NCT ID: NCT03016975
Last Updated: 2023-11-30
Results Overview
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).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
1 year
Results posted on
2023-11-30
Participant Flow
Participant milestones
| Measure |
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.
|
Experimental: Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
|---|---|---|---|
|
At 30 Days Follow-up
STARTED
|
12
|
0
|
0
|
|
At 30 Days Follow-up
COMPLETED
|
11
|
0
|
0
|
|
At 30 Days Follow-up
NOT COMPLETED
|
1
|
0
|
0
|
|
At 6 Months Follow-up
STARTED
|
11
|
0
|
0
|
|
At 6 Months Follow-up
COMPLETED
|
6
|
0
|
0
|
|
At 6 Months Follow-up
NOT COMPLETED
|
5
|
0
|
0
|
|
At 1 Year Follow-up
STARTED
|
6
|
0
|
0
|
|
At 1 Year Follow-up
COMPLETED
|
6
|
0
|
0
|
|
At 1 Year Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
|
At 2 Year Follow-up
STARTED
|
6
|
0
|
0
|
|
At 2 Year Follow-up
COMPLETED
|
5
|
0
|
0
|
|
At 2 Year Follow-up
NOT COMPLETED
|
1
|
0
|
0
|
|
At 3 Year Follow-up
STARTED
|
5
|
0
|
0
|
|
At 3 Year Follow-up
COMPLETED
|
3
|
0
|
0
|
|
At 3 Year Follow-up
NOT COMPLETED
|
2
|
0
|
0
|
|
At 4-year Follow-up
STARTED
|
3
|
0
|
0
|
|
At 4-year Follow-up
COMPLETED
|
2
|
0
|
0
|
|
At 4-year Follow-up
NOT COMPLETED
|
1
|
0
|
0
|
|
At 5-year Follow-up
STARTED
|
2
|
0
|
0
|
|
At 5-year Follow-up
COMPLETED
|
2
|
0
|
0
|
|
At 5-year Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Experimental: Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
|---|---|---|---|
|
At 30 Days Follow-up
Subject is a Screen failure
|
1
|
0
|
0
|
|
At 6 Months Follow-up
Death
|
2
|
0
|
0
|
|
At 6 Months Follow-up
Subject withdrawn by investigator
|
1
|
0
|
0
|
|
At 6 Months Follow-up
Re-attempt procedure
|
1
|
0
|
0
|
|
At 6 Months Follow-up
Aborted implant
|
1
|
0
|
0
|
|
At 2 Year Follow-up
Death
|
1
|
0
|
0
|
|
At 3 Year Follow-up
Death
|
1
|
0
|
0
|
|
At 3 Year Follow-up
Withdrawal by Subject
|
1
|
0
|
0
|
|
At 4-year Follow-up
Exited Study for other reasons
|
1
|
0
|
0
|
Baseline Characteristics
Data unavailable for 3 patients
Baseline characteristics by cohort
| Measure |
Roll-in
n=12 Participants
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.
|
Experimental: Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.8 years
STANDARD_DEVIATION 9.60 • n=12 Participants
|
—
|
—
|
71.8 years
STANDARD_DEVIATION 9.60 • n=12 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=12 Participants
|
—
|
—
|
2 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=12 Participants
|
—
|
—
|
10 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants • Data unavailable for 3 patients
|
—
|
—
|
0 Participants
n=9 Participants • Data unavailable for 3 patients
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants • Data unavailable for 3 patients
|
—
|
—
|
0 Participants
n=9 Participants • Data unavailable for 3 patients
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants • Data unavailable for 3 patients
|
—
|
—
|
0 Participants
n=9 Participants • Data unavailable for 3 patients
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants • Data unavailable for 3 patients
|
—
|
—
|
1 Participants
n=9 Participants • Data unavailable for 3 patients
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants • Data unavailable for 3 patients
|
—
|
—
|
8 Participants
n=9 Participants • Data unavailable for 3 patients
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants • Data unavailable for 3 patients
|
—
|
—
|
0 Participants
n=9 Participants • Data unavailable for 3 patients
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • Data unavailable for 3 patients
|
—
|
—
|
0 Participants
n=9 Participants • Data unavailable for 3 patients
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
—
|
—
|
12 participants
n=12 Participants
|
|
NYHA Functional Class
Class 1
|
0 Participants
n=12 Participants
|
—
|
—
|
0 Participants
n=12 Participants
|
|
NYHA Functional Class
Class II
|
5 Participants
n=12 Participants
|
—
|
—
|
5 Participants
n=12 Participants
|
|
NYHA Functional Class
Class III
|
6 Participants
n=12 Participants
|
—
|
—
|
6 Participants
n=12 Participants
|
|
NYHA Functional Class
Class IV
|
1 Participants
n=12 Participants
|
—
|
—
|
1 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: No patients were randomized, therefore no data was collected. This parameter is meant to be analyzed in hierarchical order for the randomized arms only.
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 30 daysPopulation: No patients were randomized, therefore no data was collected in the randomized phase.
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
Outcome measures
| Measure |
Experimental: Edwards Cardioband System
n=8 Participants
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
|---|---|---|---|
|
Number of Participants With Major Adverse Events (MAE) [Device Group Only]
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: No patients were randomized, therefore no data was collected
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
Outcome measures
| Measure |
Experimental: Edwards Cardioband System
n=8 Participants
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
|---|---|---|---|
|
Secondary Safety Endpoints [Device Group Only]
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: No patients were randomized, therefore no data was collected. The parameter is meant to be analyzed in hierarchical order for the 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: No patients were randomized, therefore no data was collected in the randomized phase.
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).
Outcome measures
| Measure |
Experimental: Edwards Cardioband System
n=12 Participants
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
|---|---|---|---|
|
Device Success
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: No patients were randomized, therefore no data was collected in the randomized phase.
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).
Outcome measures
| Measure |
Experimental: Edwards Cardioband System
n=12 Participants
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
|---|---|---|---|
|
Procedural Success
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: No patients were randomized, therefore no data was collected in the randomized phase.
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.
Outcome measures
| Measure |
Experimental: Edwards Cardioband System
n=12 Participants
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
|---|---|---|---|
|
Clinical Success
|
7 Participants
|
—
|
—
|
Adverse Events
Roll-in
Serious events: 9 serious events
Other events: 8 other events
Deaths: 4 deaths
Experimental: Edwards Cardioband System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control: No Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Roll-in
n=12 participants at risk
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.
|
Experimental: Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT).
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
|---|---|---|---|
|
Cardiac disorders
Acute Left Ventricular Failure
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Atrial Fibrillation
|
16.7%
2/12 • Number of events 2 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Atrial Flutter
|
16.7%
2/12 • Number of events 3 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Cardiac Failure
|
8.3%
1/12 • Number of events 2 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Cardiac Failure Acute
|
16.7%
2/12 • Number of events 11 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Cardiac Failure Congestive
|
16.7%
2/12 • Number of events 4 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Cardiogenic Shock
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Mitral Valve Incompetence
|
8.3%
1/12 • Number of events 2 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Pericardial Effusion
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Pulmonary Oedema
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
General disorders
Death
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Infections and infestations
Clostridium Difficile Colitis
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Infections and infestations
Septic Shock
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Metabolism and nutrition disorders
Gout
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Product Issues
Device Dislocation
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Renal and urinary disorders
Urinary Retention
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
8.3%
1/12 • Number of events 4 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Ventricular Tachycardia
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Surgical and medical procedures
Cardiac Resynchronisation Therapy
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Chronic Left Ventricular Failure
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
Other adverse events
| Measure |
Roll-in
n=12 participants at risk
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.
|
Experimental: Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT).
|
Control: No Intervention
Guideline directed medical therapy (GDMT)
|
|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Atrial Fibrillation
|
16.7%
2/12 • Number of events 2 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Cardiac Failure
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Mitral Valve Incompetence
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Nodal Rhythm
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Tricuspid Valve Incompetence
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Ventricular Tachycardia
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Endocrine disorders
Hypothyroidism
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
General disorders
Asthenia
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Injury, poisoning and procedural complications
Medical Device Site Injury
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Investigations
Electrocardiogram Qt Prolonged
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Investigations
Troponin I Increased
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.3%
1/12 • Number of events 2 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
2/12 • Number of events 2 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Renal and urinary disorders
Acute Kidney Injury
|
16.7%
2/12 • Number of events 2 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Renal and urinary disorders
Renal Impairment
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Vascular disorders
Air Embolism
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Vascular disorders
Haematoma
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
|
Cardiac disorders
Bundle Branch Block Right
|
8.3%
1/12 • Number of events 1 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
—
0/0 • 5 Years
Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place