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NCT Number: NCT02033811

MitraClip® Registry

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.

Recruiting

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine

Düsseldorf, 40225, Germany

Location status: Recruiting

Location contact

Katharina Hellhammer, MD

SUB_INVESTIGATOR

Malte Kelm, MD

CONTACT

Malte Kelm, MD

PRINCIPAL_INVESTIGATOR

Patrick Horn, MD

SUB_INVESTIGATOR

Ralf Westenfeld, MD

SUB_INVESTIGATOR

Tobias Zeus, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major cardiac adverse events

    Time frame: 30 days

    increase in the 30-day risk of adverse events among patients receiving PMVR

Secondary outcomes

  1. Mortality

    Time frame: 1 year

    Proportion of patients who are alive at 1 year after receiving

Study contacts

Contact information is provided by the study sponsor or research team.

Malte Kelm, MD

CONTACT

0049 211 81 18800

Sponsors and collaborators

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2030
Study completion
2030
First posted
Jan 13, 2014
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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