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MitraClip® Registry

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ClinicalTrials.gov Identifier: NCT02033811
Recruitment Status : Recruiting
First Posted : January 13, 2014
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

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.


Condition or disease
Mitral Regurgitation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: MitraClip® Registry - an Observational Study of Percutaneous Mitral Valve Repair Using the MitraClip® System
Study Start Date : January 2014
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020



Primary Outcome Measures :
  1. Major cardiac adverse events [ Time Frame: 30 days ]
    increase in the 30-day risk of adverse events among patients receiving PMVR


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 1 year ]
    Proportion of patients who are alive at 1 year after receiving



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing percutaneous mitral valve repair (PMVR) with the MitraClip® system
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033811


Contacts
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Contact: Malte Kelm, MD 0049 211 81 18800

Locations
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Germany
Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine Recruiting
Dusseldorf, Germany, 40225
Contact: Malte Kelm, MD         
Principal Investigator: Malte Kelm, MD         
Sub-Investigator: Ralf Westenfeld, MD         
Sub-Investigator: Tobias Zeus, MD         
Sub-Investigator: Katharina Hellhammer, MD         
Sub-Investigator: Patrick Horn, MD         
Sponsors and Collaborators
Klinik für Kardiologie, Pneumologie und Angiologie
Investigators
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Principal Investigator: Malte Kelm, MD Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study Chair: Malte Kelm, MD Division of Cardiology, Pulmonary Disease and Vascular Medicine

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Director Division of Cardiology, Pulmonary Disease and Vascular Medicine, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02033811     History of Changes
Other Study ID Numbers: MitraClip® Registry
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
mitral regurgitation
MitraClip system
percutaneous mitral valve repair
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases