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Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE) (ACTIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016975
Recruitment Status : Active, not recruiting
First Posted : January 11, 2017
Results First Posted : November 9, 2022
Last Update Posted : January 10, 2023
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Functional Mitral Regurgitation
Mitral Regurgitation
Mitral Insufficiency
Interventions Device: Edwards Cardioband System
Drug: Guideline Directed Medical Therapy
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Roll-in Experimental: Edwards Cardioband System Control: No Intervention
Hide Arm/Group Description

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.

Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) Guideline directed medical therapy (GDMT)
Period Title: At 30 Days Follow-up
Started 12 0 0
Completed 11 0 0
Not Completed 1 0 0
Reason Not Completed
Subject is a Screen failure             1             0             0
Period Title: At 6 Months Follow-up
Started 11 0 0
Completed 6 0 0
Not Completed 5 0 0
Reason Not Completed
Death             2             0             0
Subject withdrawn by investigator             1             0             0
Re-attempt procedure             1             0             0
Aborted implant             1             0             0
Period Title: At 1 Year Follow-up
Started 6 0 0
Completed 6 0 0
Not Completed 0 0 0
Period Title: At 2 Year Follow-up
Started 6 0 0
Completed 5 0 0
Not Completed 1 0 0
Reason Not Completed
Death             1             0             0
Period Title: At 3 Year Follow-up
Started 5 0 0
Completed 3 0 0
Not Completed 2 0 0
Reason Not Completed
Death             1             0             0
Withdrawal by Subject             1             0             0
Arm/Group Title Roll-in Experimental: Edwards Cardioband System Control: No Intervention Total
Hide Arm/Group Description

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.

Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) Guideline directed medical therapy (GDMT) Total of all reporting groups
Overall Number of Baseline Participants 12 0 0 12
Hide Baseline Analysis Population Description
Data were not collected for the experimental or control group.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 0 participants 0 participants 12 participants
71.8  (9.60) 71.8  (9.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 0 participants 0 participants 12 participants
Female
2
  16.7%
2
  16.7%
Male
10
  83.3%
10
  83.3%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 0 participants 0 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
1
  11.1%
1
  11.1%
White
8
  88.9%
8
  88.9%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Data unavailable for 3 patients
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 0 participants 0 participants 12 participants
12 12
NYHA Functional Class   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 0 participants 0 participants 12 participants
Class 1
0
   0.0%
0
   0.0%
Class II
5
  41.7%
5
  41.7%
Class III
6
  50.0%
6
  50.0%
Class IV
1
   8.3%
1
   8.3%
[1]
Measure Description:

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
1.Primary Outcome
Title 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)].
Hide Description 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).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were randomized, therefore no data was collected. This parameter is meant to be analyzed in hierarchical order for the randomized arms only.
Arm/Group Title Experimental: Edwards Cardioband System Control: No Intervention
Hide Arm/Group Description:
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Guideline directed medical therapy (GDMT)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Number of Participants With Major Adverse Events (MAE) [Device Group Only]
Hide Description 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
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were randomized, therefore no data was collected in the randomized phase.
Arm/Group Title Roll-in Experimental: Edwards Cardioband System Control: No Intervention
Hide Arm/Group Description:
Transcatheter mitral valve repair with the Edwards Cardioband System. This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment.
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Guideline directed medical therapy (GDMT)
Overall Number of Participants Analyzed 8 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Secondary Safety Endpoints [Device Group Only]
Hide Description

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
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were randomized, therefore no data was collected
Arm/Group Title Roll-in Experimental: Edwards Cardioband System Control: No Intervention
Hide Arm/Group Description:
Transcatheter mitral valve repair with the Edwards Cardioband System. This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment.
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Guideline directed medical therapy (GDMT)
Overall Number of Participants Analyzed 8 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only)
Hide Description

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
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were randomized, therefore no data was collected. The parameter is meant to be analyzed in hierarchical order for the randomized arms only.
Arm/Group Title Experimental: Edwards Cardioband System Control: No Intervention
Hide Arm/Group Description:
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Guideline directed medical therapy (GDMT)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Device Success
Hide Description 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).
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were randomized, therefore no data was collected in the randomized phase.
Arm/Group Title Roll-in Experimental: Edwards Cardioband System Control: No Intervention
Hide Arm/Group Description:
Transcatheter mitral valve repair with the Edwards Cardioband System. This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment.
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Guideline directed medical therapy (GDMT)
Overall Number of Participants Analyzed 12 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
8
  66.7%
6.Secondary Outcome
Title Procedural Success
Hide Description 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).
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were randomized, therefore no data was collected in the randomized phase.
Arm/Group Title Roll-in Experimental: Edwards Cardioband System Control: No Intervention
Hide Arm/Group Description:
Transcatheter mitral valve repair with the Edwards Cardioband System. This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment.
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Guideline directed medical therapy (GDMT)
Overall Number of Participants Analyzed 12 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
7
  58.3%
7.Secondary Outcome
Title Clinical Success
Hide Description

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.

Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were randomized, therefore no data was collected in the randomized phase.
Arm/Group Title Roll-in Experimental: Edwards Cardioband System Control: No Intervention
Hide Arm/Group Description:
Transcatheter mitral valve repair with the Edwards Cardioband System. This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment.
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Guideline directed medical therapy (GDMT)
Overall Number of Participants Analyzed 12 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
7
  58.3%
Time Frame 3 Years
Adverse Event Reporting Description Trial was designed for patients to be randomized. No patients were randomized, therefore no data was collected for experimental or control groups
 
Arm/Group Title Roll-in Experimental: Edwards Cardioband System Control: No Intervention
Hide Arm/Group Description

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.

Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT). Guideline directed medical therapy (GDMT)
All-Cause Mortality
Roll-in Experimental: Edwards Cardioband System Control: No Intervention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/12 (33.33%)      0/0      0/0    
Hide Serious Adverse Events
Roll-in Experimental: Edwards Cardioband System Control: No Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/12 (66.67%)      0/0      0/0    
Cardiac disorders       
Acute Left Ventricular Failure   1/12 (8.33%)  1 /0  /0 
Atrial Fibrillation   1/12 (8.33%)  1 /0  /0 
Atrial Flutter   2/12 (16.67%)  3 /0  /0 
Cardiac Failure   1/12 (8.33%)  2 /0  /0 
Cardiac Failure Acute   2/12 (16.67%)  12 /0  /0 
Cardiac Failure Congestive   2/12 (16.67%)  4 /0  /0 
Cardiogenic Shock   1/12 (8.33%)  1 /0  /0 
Mitral Valve Incompetence   1/12 (8.33%)  1 /0  /0 
Pericardial Effusion   1/12 (8.33%)  1 /0  /0 
Pulmonary Oedema   1/12 (8.33%)  1 /0  /0 
General disorders       
Death   1/12 (8.33%)  1 /0  /0 
Infections and infestations       
Clostridium Difficile Colitis   1/12 (8.33%)  1 /0  /0 
Sepsis   1/12 (8.33%)  1 /0  /0 
Septic Shock   1/12 (8.33%)  1 /0  /0 
Injury, poisoning and procedural complications       
Aortic Perforation   1/12 (8.33%)  1 /0  /0 
Clavicle Fracture   1/12 (8.33%)  1 /0  /0 
Subdural Haematoma   1/12 (8.33%)  1 /0  /0 
Investigations       
Prostatic Specific Antigen Increased   1/12 (8.33%)  1 /0  /0 
Metabolism and nutrition disorders       
Dehydration   1/12 (8.33%)  1 /0  /0 
Gout   1/12 (8.33%)  1 /0  /0 
Hypomagnesaemia   1/12 (8.33%)  1 /0  /0 
Product Issues       
Device Dislocation   1/12 (8.33%)  1 /0  /0 
Renal and urinary disorders       
Urinary Retention   1/12 (8.33%)  1 /0  /0 
Respiratory, thoracic and mediastinal disorders       
Pleural Effusion   1/12 (8.33%)  4 /0  /0 
Pulmonary Embolism   1/12 (8.33%)  1 /0  /0 
Vascular disorders       
Hypotension   1/12 (8.33%)  1 /0  /0 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Roll-in Experimental: Edwards Cardioband System Control: No Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/12 (58.33%)      0/0      0/0    
Cardiac disorders       
Acute Myocardial Infarction   1/12 (8.33%)  1 /0  /0 
Atrial Fibrillation   1/12 (8.33%)  1 /0  /0 
Atrioventricular Block First Degree   1/12 (8.33%)  1 /0  /0 
Cardiac Failure   2/12 (16.67%)  2 /0  /0 
Mitral Valve Incompetence   1/12 (8.33%)  2 /0  /0 
Nodal Rhythm   1/12 (8.33%)  1 /0  /0 
Supraventricular Extrasystoles   1/12 (8.33%)  1 /0  /0 
Tricuspid Valve Incompetence   1/12 (8.33%)  1 /0  /0 
Ventricular Tachycardia   1/12 (8.33%)  1 /0  /0 
Endocrine disorders       
Hypothyroidism   1/12 (8.33%)  1 /0  /0 
General disorders       
Asthenia   1/12 (8.33%)  1 /0  /0 
Infections and infestations       
Bronchitis   1/12 (8.33%)  1 /0  /0 
Rectal Abcess   1/12 (8.33%)  1 /0  /0 
Viral Upper Respiratory Tract Infection   1/12 (8.33%)  1 /0  /0 
Injury, poisoning and procedural complications       
Humerus Fracture   1/12 (8.33%)  1 /0  /0 
Medical Device Site Injury   1/12 (8.33%)  1 /0  /0 
Investigations       
Electrocardiogram Qt Prolonged   1/12 (8.33%)  1 /0  /0 
Troponin I Increased   1/12 (8.33%)  1 /0  /0 
Metabolism and nutrition disorders       
Hypercalcaemia   1/12 (8.33%)  1 /0  /0 
Hyperkalaemia   1/12 (8.33%)  1 /0  /0 
Hypoalbuminaemia   1/12 (8.33%)  2 /0  /0 
Hypokalaemia   2/12 (16.67%)  2 /0  /0 
Musculoskeletal and connective tissue disorders       
Pain In Extremity   1/12 (8.33%)  1 /0  /0 
Renal and urinary disorders       
Acute Kidney Injury   1/12 (8.33%)  1 /0  /0 
Renal Failure   1/12 (8.33%)  1 /0  /0 
Renal Impairment   1/12 (8.33%)  1 /0  /0 
Respiratory, thoracic and mediastinal disorders       
Atelectasis   1/12 (8.33%)  1 /0  /0 
Vascular disorders       
Air Embolism   1/12 (8.33%)  1 /0  /0 
Haematoma   1/12 (8.33%)  1 /0  /0 
Hypotension   1/12 (8.33%)  1 /0  /0 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ted Feldman
Organization: Edwards Lifesciences
Phone: 949-250-2500
EMail: Feldman_Info@edwards.com
Layout table for additonal information
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03016975    
Other Study ID Numbers: 2017-05
First Submitted: January 8, 2017
First Posted: January 11, 2017
Results First Submitted: April 13, 2022
Results First Posted: November 9, 2022
Last Update Posted: January 10, 2023