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High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Trial Comparing MitraClip® to Surgical Therapy

NCT02534155 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2016-09-09

No results posted yet for this study

Summary

The study is comparing MitraClip® to Surgical therapy in high and intermediate risk patients, who should be older than 18 years, and shall evaluate safety and efficacy of MitraClip® vs. surgery in high or intermediate risk patients. The patients will be randomised (MitraClip® or Surgery). The Study Follow-Up includes 4 visits after procedure (hospital discharge, 1, 6, 12 months post-procedure).

Conditions

  • Mitral Valve Insufficiency

Interventions

DEVICE

MitraClip®

one or more (if needed) MitraClip® devices are placed on the leaflets of the mitral valve during catheterisation in a catheter laboratory

PROCEDURE

Mitral valve Surgery

Repair or replace mitral valve

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Francesco Maisano, Prof. · Universitätspital Zürich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-09-30
Completion
2018-09-30

Countries

  • Germany
  • Italy
  • Switzerland

Study Locations

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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 NCT02534155 on ClinicalTrials.gov