Functional Mitral RegurgitationACTIVENCT03016975

Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)

A study testing Edwards Cardioband System and Guideline Directed Medical Therapy in people with Functional Mitral Regurgitation and Mitral Regurgitation, run by Edwards Lifesciences at 24 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Insufficiency
What is being tested?: Edwards Cardioband System and Guideline Directed Medical Therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 24 sitesUnited States
Study dates: 1 Jun 2017to 20 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age > 18 years;
Clinically Significant Functional Mitral Regurgitation (MR);
Symptomatic heart failure;
Patient hospitalized due to heart failure during 12 months prior to submission to Central Screening Committee OR elevated Brain Natriuretic Peptid (BNP);
Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit compliance.

Who cannot join

Primarily degenerative MR;
Mitral annular calcification that would impede implantation of device;
Other severe valve disorders requiring intervention;
Mitral valve anatomy which may preclude proper Edwards Cardioband deployment;
Life expectancy of less than twelve months;
Patient is participating in concomitant research studies of investigational products which have not reached their primary endpoint;
Unwillingness or inability to undergo follow-up investigations/visits;
Other medical, social, or psychological conditions that precludes appropriate consent and follow-up

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Emory University Hospital
Atlanta, Georgia, 30322
University of Colorado Denver
Aurora, Colorado, 80045
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Sanger Heart & Vascular Institute - Atrium Health
Charlotte, North Carolina, 28203
University of Virginia Health System
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Henry Ford Hospital
Detroit, Michigan, 48202
Pinnacle Health
Harrisburg, Pennsylvania, 17101
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
St. Vincent Heart Center
Indianapolis, Indiana, 46290
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Morristown Medical Center
Morristown, New Jersey, 07960
Intermountain Medical Center
Murray, Utah, 84107
NYU Langone Health
New York, New York, 10016
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Lenox Hill Hospital - Northwell Health
New York, New York, 10075
Stanford University
Palo Alto, California, 94304
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Providence Health &Services, Heart & Vascular Institute
Portland, Oregon, 97225
Oregon Health & Science University
Portland, Oregon, 97239
St. Francis Hospital
Roslyn, New York, 11576
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: Annular ReduCtion for Transcatheter Treatment of Insufficient Mitral ValvE (ACTIVE): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Assess Transcatheter Mitral Valve Repair With Edwards Cardioband System and GDMT vs GDMT Alone in Patients With FMR and Heart Failure

To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).

Read the detailed description

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.

Conditions: Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Insufficiency
Being tested: Edwards Cardioband System, Guideline Directed Medical Therapy
Keywords: Edwards Cardioband, Mitral Valve, Transcatheter, Mitral repair, Functional mitral regurgitation, Secondary mitral regurgitation, Annuloplasty
Medical subject headings: Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Edwards Cardioband SystemDevice
Also called Transcatheter mitral valve repair (TMVr)
Transcatheter mitral valve repair with the Edwards Cardioband System
Guideline Directed Medical TherapyDrug
GDMT Only

Study groups in NCT03016975
Study group	Role	What they receive
Randomized - Edwards Cardioband System	Experimental	Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) Receives: Device: Edwards Cardioband System; Drug: Guideline Directed Medical Therapy
Randomized - Control	Active comparator	Guideline directed medical therapy (GDMT) Receives: Drug: Guideline Directed Medical Therapy
Roll-In - Edwards Cardioband System	Experimental	Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) Receives: Device: Edwards Cardioband System; Drug: Guideline Directed Medical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
Measured: 30 days

Secondary outcomes (5)

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
Measured: 30 days
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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201720 Sep 2022

First posted11 Jan 2017 (estimated)
Study start1 Jun 2017
Primary completion19 Jul 2019
Study completion20 Sep 2022

Why it stopped: Procedure and device development

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Functional Mitral RegurgitationStudies of the same condition, open and under way.
More trials run by Edwards LifesciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03016975
Sponsor's protocol ID: 2017-05
Acronym: ACTIVE
Status last verified: Nov 2023
First submitted: 8 Jan 2017
Last updated: 30 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Recruiting
Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
Functional Mitral Regurgitation
Recruiting
Effects of tDCS for Enhancing Cognitive Function in Individuals With Persistent Post-Concussion Syndrome
Transcranial Direct Current Stimulation, Post-Concussion Syndrome

All Functional Mitral Regurgitation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Annular ReduCtion for Transcatheter Treatment of Insufficient Mitral ValvE (ACTIVE): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Assess Transcatheter Mitral Valve Repair With Edwards Cardioband System and GDMT vs GDMT Alone in Patients With FMR and Heart Failure
ClinicalTrials.gov ID: NCT03016975
Acronym / sponsor ID: ACTIVE / 2017-05
Conditions: Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Insufficiency
Keywords: Edwards Cardioband, Mitral Valve, Transcatheter, Mitral repair, Functional mitral regurgitation, Secondary mitral regurgitation, Annuloplasty
Study type: Interventional
Recruitment status: TerminatedReason stopped: Procedure and device development
Enrolment: 12 participants (actual)
Lead sponsor: Edwards LifesciencesIndustry (pharma, biotech, devices)
Study start: 1 Jun 2017 (actual)
Primary completion: 19 Jul 2019 (actual)
Study completion: 20 Sep 2022 (actual)
First posted: 11 Jan 2017 (estimated)
Results: Posted 9 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Randomized - Edwards Cardioband System	Experimental	Device: Edwards Cardioband System, Drug: Guideline Directed Medical TherapyTranscatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Randomized - Control	Active comparator	Drug: Guideline Directed Medical TherapyGuideline directed medical therapy (GDMT)
Roll-In - Edwards Cardioband System	Experimental	Device: Edwards Cardioband System, Drug: Guideline Directed Medical TherapyTranscatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age > 18 years;
Clinically Significant Functional Mitral Regurgitation (MR);
Symptomatic heart failure;
Patient hospitalized due to heart failure during 12 months prior to submission to Central Screening Committee OR elevated Brain Natriuretic Peptid (BNP);
Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit compliance.

Key exclusion criteria (8 listed)

Primarily degenerative MR;
Mitral annular calcification that would impede implantation of device;
Other severe valve disorders requiring intervention;
Mitral valve anatomy which may preclude proper Edwards Cardioband deployment;
Life expectancy of less than twelve months;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Edwards Cardioband SystemAlso: Transcatheter mitral valve repair (TMVr)Transcatheter mitral valve repair with the Edwards Cardioband System	Device	Randomized - Edwards Cardioband System, Roll-In - Edwards Cardioband System
Guideline Directed Medical TherapyGDMT Only	Drug	Randomized - Control, Randomized - Edwards Cardioband System, Roll-In - Edwards Cardioband System

Primary outcome

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)].
Time frame: 1 year
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).
Number of Participants With Major Adverse Events (MAE) [Device Group Only]
Time frame: 30 days
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

5 secondary outcomes

Secondary Safety Endpoints [Device Group Only]
Time frame: 30 days
Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only)
Time frame: 1 year
Device Success
Time frame: 30 days
Procedural Success
Time frame: 30 days
Clinical Success
Time frame: 30 days

Results and safety

Results posted to the registry on 9 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Roll-in	12	11
Experimental: Edwards Cardioband System	0	0
Control: No Intervention	0	0

Primary outcome: 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)].

Time frame: 1 year

Population analysed: No patients were randomized, therefore no data was collected. This parameter is meant to be analyzed in hierarchical order for the randomized arms only.

Primary outcome: Number of Participants With Major Adverse Events (MAE) [Device Group Only]

Time frame: 30 days. Count of participants. Unit: Participants

Measure	Roll-in n = 8	Experimental: Edwards Cardioband System n = 0	Control: No Intervention n = 0
Value	0	–	–

Population analysed: No patients were randomized, therefore no data was collected in the randomized phase.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 Years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Roll-in	9 of 12 (75%)	8 of 12 (66.7%)	4 of 12
Experimental: Edwards Cardioband System	0 of 0	0 of 0	0
Control: No Intervention	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Functional Mitral Regurgitation

Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Recruiting
Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
Functional Mitral Regurgitation
Recruiting
Effects of tDCS for Enhancing Cognitive Function in Individuals With Persistent Post-Concussion Syndrome
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian Whisenant, MD principal investigator

Intermountain Health Care, Inc.

Vinod Thourani, MD principal investigator

Piedmont Heart Institute

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)]. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03016975.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.