MitraClip® Registry

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02033811

Enrollment

200

Registered

2014-01-13

Start date

2014-01-31

Completion date

2030-12-31

Last updated

2020-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Keywords

mitral regurgitation, MitraClip system, percutaneous mitral valve repair

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Major cardiac adverse events	30 days	increase in the 30-day risk of adverse events among patients receiving PMVR

Secondary

Measure	Time frame	Description
Mortality	1 year	Proportion of patients who are alive at 1 year after receiving

Countries

Germany

Contacts

Primary ContactMalte Kelm, MD

0049 211 81 18800

Outcome results