MedTrace Logo

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

NCT02985268 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-02-27

No results posted yet for this study

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

Interventions

DEVICE

MitraClip

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.

DRUG

Optimal Medical Therapy

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

DEVICE

CRT-D

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

Sponsors & Collaborators

  • Montreal Heart Institute

    lead OTHER

Principal Investigators

  • Anita Asgar, MD · Montreal Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-12-31
Completion
2020-02-29

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02985268 on ClinicalTrials.gov