Evaluation of Outcomes of CRT and MitraClip for Treatment of Low Ejection Fraction and Functional Mitral Regurgitation in HF

NCT02985268 | Withdrawn DMC

• 1 other identifier: MHICC-2016-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

At present, the optimal treatment strategy for heart failure patients and moderate-to-severe (3+) or severe (4+) mitral regurgitation with a class IIa recommendation for CRT is uncertain.Whether these patents should also be treated for functional mitral regurgitation or with CRT also remains unclear. We therefore propose a randomized 2x2 factorial design in this patient population to understand the the impact of both CRT and transcatheter mitral valve repair with the MitraClip on their functional status and quality of life.

Conditions

Functional Mitral Regurgitation; Heart Failure

Keywords

MitraClip; Cardiovascular resynchronization therapy; Six minute walk test; Mitral regurgitation; CRT-D

Outcome Measures

Primary Outcomes (1)

• Improvement in distance walked on a six-minute walk test (6MWT)

  Baseline to 6 months

Secondary Outcomes (6)

• Change in cardiographic endpoints

  Baseline to 6 months

• Change in cardiographic endpoints

  Baseline to 6 months

• Change in cardiographic endpoints

  Baseline to 6 months

• Change in Quality of Life Assessment scores

  Baseline to 6 months

• Change in Quality of Life Assessment scores

  Baseline to 6 months

Other Outcomes (2)

• Wearable activity/heart rate sensor (Fitbit Charge 2)

  12 months

• Major Adverse Cardiac Event (MACE)

  12 months

Study Arms (4)

MitraClip/Optimal Medical Therapy (OMT) and CRT ON

ACTIVE COMPARATOR

Patient to be implanted with both MitraClip and CRT-D. Will also receive optimal medical therapy. CRT-D will be programmed to ON

Device: MitraClip; Drug: Optimal Medical Therapy; Device: CRT-D

MitraClip/OMT and CRT OFF

ACTIVE COMPARATOR

Patient to be implanted with both MitraClip and CRT-D. Will also receive optimal medical therapy. CRT-D will be programmed to OFF until the 6-month follow-up visit in which the CRT will be turned ON

Device: MitraClip; Drug: Optimal Medical Therapy; Device: CRT-D

OMT and CRT ON

ACTIVE COMPARATOR

Patient to be implanted with only the CRT-D and will receive optimal medical therapy. CRT-D will be programmed to ON

Drug: Optimal Medical Therapy; Device: CRT-D

OMT and CRT OFF

ACTIVE COMPARATOR

Patient to be implanted with only the CRT-D and will receive optimal medical therapy. CRT-D will be programmed to OFF until the 6-month follow-up visit in which the CRT will be turned ON

Drug: Optimal Medical Therapy; Device: CRT-D

Interventions

MitraClip DEVICE

The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus \[degenerative MR\] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

MitraClip/OMT and CRT OFF; MitraClip/Optimal Medical Therapy (OMT) and CRT ON

Optimal Medical Therapy DRUG

Optimal medical therapy administered as per the Guideline Direct Medical Therapy (GDMT) as defined in the 2013 ACCF/AHA Heart Failure Guidelines with maximum tolerated doses of an ACE-inhibitor or Angiotensin Receptor Blocker (ARB) and beta-blocker

Also known as: OMT

MitraClip/OMT and CRT OFF; MitraClip/Optimal Medical Therapy (OMT) and CRT ON; OMT and CRT OFF; OMT and CRT ON

CRT-D DEVICE

Cardiac Resynchronization Therapy with defibrillation therapy devices will be implanted according to the Heart Rhythm Society Guidelines for implanted devices.

Also known as: Cardiac Resynchronization Therapy and Defibrillator

MitraClip/OMT and CRT OFF; MitraClip/Optimal Medical Therapy (OMT) and CRT ON; OMT and CRT OFF; OMT and CRT ON

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology as determined by transthoracic echocardiogram (TTE), and confirmed by the Echocardiography Core Lab (ECL);
• Symptomatic heart failure as defined by New York Heart Association (NYHA) class II, III or ambulatory IV;
• Treatment and compliance with optimal medical therapy for heart failure for at least 30 days; Optimal medical therapy is defined by: Maximum tolerated beta-blocker, angiotensin converting enzyme inhibitor (ACE) or angiotensin receptor blocker (ARB), and aldosterone antagonist (as per the ACCF/AHA Guidelines as judged by the HF specialist investigator on site and confirmed by the Clinical Eligibility Committee).
• Left ventricular ejection fraction ≤ 35%, as assessed by any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI);
• Class IIa indication for cardiac resynchronization therapy:
• Left bundle branch block (LBBB) and QRS duration of 120-149 ms;
• Right bundle branch block (RBBB) and QRS ≥ 150 ms.
• Clinical agreement amongst local investigators that the patient will not be offered surgical intervention;
• The primary regurgitant jet, in the opinion of the MitraClip implanting investigator, can successfully be treated by the MitraClip. Treatment of commissural mitral regurgitation may be treated at the discretion of the operator. All major jets contributing the secondary MR will be treated with the MitraClip;
• Ability to perform a six-minute walk test (6MWT) without substantial physical limitations and without use of a walker or wheelchair and distance walked in 6 minutes of ≤ 450m;
• Ability and willingness to give written informed consent and to comply with the requirements of the study.

You may not qualify if:

• Life expectancy less than 12 months due to noncardiac conditions;
• ACC/AHA Stage D Heart Failure;
• Left ventricular ejection fraction ≤ 15%;
• Hypotension (systolic pressure \<90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support;
• United Network for Organ Sharing (UNOS) status 1 heart transplantation or prior orthotopic heart transplantation;
• Untreated clinically significant coronary artery disease requiring revascularization;
• CABG within prior 30 days;
• Percutaneous coronary intervention within prior 30 days;
• Severe Chronic Obstructive Pulmonary Disease (COPD) requiring continuous daytime home oxygen or chronic oral corticosteroid therapy;
• Previous surgical mitral valve bioprosthesis, mitral annuloplasty, or transcatheter mitral valve procedure;
• Positive pregnancy test, or woman of child bearing potential not using highly effective methods of contraception;
• Mitral valve area \<4.0 cm2 as assessed by planimetry of the mitral valve;
• Subjects in whom trans-esophageal echocardiography is contraindicated or high risk;
• Mitral leaflet anatomy which may preclude MitraClip implantation:
• Perforated mitral leaflets or clefts, lack of primary or secondary chordal support;

Sponsors & Collaborators

• Montreal Heart Institute: lead

MeSH Terms

Conditions

Heart Failure; Mitral Valve Insufficiency

Interventions

Cardiac Resynchronization Therapy; Defibrillators

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Anita Asgar, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 7, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share