Noninferiority Trial of MitraClip Implantation Strategies: 1 Clip vs. 2 Clips in Patients With Functional Mitral Regurgitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2020-12-31

Brief Summary

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Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk. In Europe, about two-thirds of patients treated with the MitraClip suffer from MR of functional origin secondary to ischemic or dilated cardiomyopathy. At present, there is debate among operators on whether stabilizing/supporting a single adequately implanted clip with a second clip is beneficial for patients with functional MR.

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Detailed Description

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Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk. In Europe, about two-thirds of patients treated with the MitraClip suffer from MR of functional origin secondary to ischemic or dilated cardiomyopathy. At present, there is debate among operators on whether stabilizing/supporting a single adequately implanted clip with a second clip is beneficial for patients with functional MR.

Purpose To demonstrate the noninferiority of a 1-clip strategy vs. a 2-clip strategy of MitraClip implantation, when the second clip in the 2-clip study arm is implanted for stabilizing/supporting purposes.

Conditions

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Mitral Regurgitation Functional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, multi-center, randomized, parallel-arm trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One CLIP

Implantation of single MitraClip

Group Type ACTIVE_COMPARATOR

MitraClip implantation

Intervention Type DEVICE

Device to approximate the mitral valve leaflets

Two CLIPs

Implantation of second MitraClip (after successful Implantation of single MitraClip)

Group Type ACTIVE_COMPARATOR

MitraClip implantation

Intervention Type DEVICE

Device to approximate the mitral valve leaflets

Interventions

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MitraClip implantation

Device to approximate the mitral valve leaflets

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Absence of a structural abnormality of the mitral valve giving rise to MR.
* MR severity of US grade 3+ or 4+ of central or noncentral origin
* Patient must consent to randomization in the hybrid operating theater upon successful implantation of a single MitraClip. Written informed consent must be provided prior to the MitraClip procedure.