NCT02985268

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

Evaluation of Outcomes of Cardiac Resynchronization Therapy and MitraClip for the Treatment of Low Ejection Fraction and Functional Mitral Valve Regurgitation in Heart Failure

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-12-01
• Completion: 2020-02-01
• First posted: 2016-12-07
• Last updated: 2020-02-27