MedTrace Logo

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

NCT03503851 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-01-03

No results posted yet for this study

Summary

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.

Conditions

  • Mitral Regurgitation Functional

Interventions

DEVICE

MitraClip implantation

Device to approximate the mitral valve leaflets

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Asklepios proresearch

    lead INDUSTRY

Principal Investigators

  • Karl-Heinz Kuck, MD, PHD · Asklepios Klinik St. Georg, Dept. of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2019-11-30
Completion
2020-12-31

More Related Trials

Entities

Companies

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 NCT03503851 on ClinicalTrials.gov