MitraClip® Registry

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Malte Kelm, MD; Phone Number: 0049 211 81 18800

Study Locations

• Germany
  • Dusseldorf, Germany, 40225
    • Recruiting
    • Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine
    • Sub-Investigator: Patrick Horn, MD
    • Contact: Malte Kelm, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie
• Investigators: Principal Investigator: Malte Kelm, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine

Publications and helpful links

General Publications

• Herbrand T, Eschenhagen S, Zeus T, Kehmeier E, Hellhammer K, Veulemans V, Kelm M, Balzer J. Acute reverse annular remodeling during MitraClip(R) therapy predicts improved clinical outcome in heart failure patients: a 3D echocardiography study. Eur J Med Res. 2017 Sep 20;22(1):33. doi: 10.1186/s40001-017-0273-x.
• Rammos C, Zeus T, Balzer J, Veulemans V, Hellhammer K, Niebel S, Kelm M, Rassaf T. Left Atrial and Left Ventricular Function and Remodeling Following Percutaneous Mitral Valve Repair. J Heart Valve Dis. 2016 May;25(3):309-319.
• Hellhammer K, Zeus T, Balzer J, van Hall S, Rammos C, Wagstaff R, Kelm M, Rassaf T. Safety and efficacy of percutaneous mitral valve repair using the MitraClip(R) system in patients with diabetes mellitus. PLoS One. 2014 Nov 6;9(11):e111178. doi: 10.1371/journal.pone.0111178. eCollection 2014.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2030
• Study Completion (ANTICIPATED): December 1, 2030

Study Registration Dates

• First Submitted: January 9, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (ESTIMATE): January 13, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: mitral regurgitation; MitraClip system; percutaneous mitral valve repair
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: MitraClip® Registry