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NCT02033811 Clinical Trial

MitraClip® Registry

Mitral Regurgitation Clinical Trial

Official title:
MitraClip® Registry - an Observational Study of Percutaneous Mitral Valve Repair Using the MitraClip® System

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02033811
Other study ID # MitraClip® Registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2014
Est. completion date December 2030

Study information
Verified date February 2020
Source Heinrich-Heine University, Duesseldorf
Contact Malte Kelm, MD
Phone 0049 211 81 18800
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients.

The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end observational study to assess the characteristics and outcomes patients with severe mitral regurgitation undergoing PMVR.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2030
Est. primary completion date December 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- severe mitral regurgitation

- percutaneous mitral valve repair (PMVR) with the MitraClip® system

Exclusion Criteria:

- < 18 years

- Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine Dusseldorf

Sponsors (1)
Lead Sponsor Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major cardiac adverse events increase in the 30-day risk of adverse events among patients receiving PMVR 30 days
Secondary Mortality Proportion of patients who are alive at 1 year after receiving 1 year
See also
  Status Clinical Trial Phase
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Suspended NCT04960280 - A Study to Evaluate a Computerized Stethoscope Called ©Voqx to Diagnose Heart Disease N/A
Recruiting NCT05021614 - Valveclip® Transcatheter Mitral Valve Repair Study N/A
Not yet recruiting NCT06465745 - AltaValve Pivotal Trial N/A
Not yet recruiting NCT06167213 - ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral N/A
Withdrawn NCT05040451 - Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
Withdrawn NCT03714412 - Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System N/A
Recruiting NCT02592889 - (MitraClip in Non-Responders to Cardiac Resynchronization Therapy) Phase 4
Completed NCT02355418 - The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation
Completed NCT01841554 - Cardioband With Transfemoral Delivery System N/A
Not yet recruiting NCT01431222 - Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery Phase 4
Not yet recruiting NCT03870516 - Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery N/A
Active, not recruiting NCT03230747 - SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation N/A
Enrolling by invitation NCT04031274 - Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry
Completed NCT05850026 - Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
Completed NCT05836480 - Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
Completed NCT05836532 - Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Recruiting NCT03975998 - Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
Completed NCT01162083 - Identifying an Ideal Cardiopulmonary Exercise Test Parameter N/A
Suspended NCT00787293 - Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients Phase 2

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