CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry
- Conditions
- Mitral Regurgitation
- Registration Number
- NCT04688190
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Brief Summary
This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- clinically significant mitral insufficiency
- patient underwent screening for TMVI
- echocardiography data at baseline (and after TMVI, E2E and surgery)
- follow-up of at least 30 days
- age under 18 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mitral insufficiency grade 2+ or more 12 months Mitral insufficiency measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.
Freedom from device-related complications 30 days
- Secondary Outcome Measures
Name Time Method All-cause mortality 12 months Combined all-cause mortality or rehospitalization for congestive heart failure 12 months Rehospitalization for congestive heart failure 12 months Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews.
Unplanned mitral valve intervention 12 months Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or left ventricular assist device implantation, e.g. as assessed by patient interviews.
Cardiovascular mortality 12 months Combined cardiovascular mortality or rehospitalization for congestive heart failure 12 months Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention 12 months Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention 12 months New York Heart Association (NYHA) stage III or IV 12 months Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient) after 12 months follow-up, as assessed by patient interviews.
Trial Locations
- Locations (26)
Cedars-Sinai Medical Center, Los Angeles
🇺🇸Los Angeles, California, United States
Goethe-Universität - University Hospital Frankfurt
🇩🇪Frankfurt, Germany
Civils Hospices of Lyon
🇫🇷Lyon, France
HDZ Bad Oeynhausen
🇩🇪Bad Oeynhausen, Germany
Heart Center Bonn
🇩🇪Bonn, Germany
St. Paul's Hospital
🇨🇦Vancouver, Canada
LMU Munich
🇩🇪Munich, Germany
Rigshospitalet
🇩🇰Copenhagen, Denmark
University Heart and Vascular Center Hamburg
🇩🇪Hamburg, Germany
San Raffaele University Hospital
🇮🇹Milan, Italy
University Hospital of Cologne
🇩🇪Cologne, Germany
German Heart Center Berlin
🇩🇪Berlin, Germany
Lille University Hospital
🇫🇷Lille, France
Toronto Heart Center
🇨🇦Toronto, Canada
German Heart Centre Munich
🇩🇪Munich, Germany
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
St Vincent's Hospital
🇦🇺Sydney, Australia
CHU Bordeaux
🇫🇷Bourdeaux, France
Clinique Pasteur
🇫🇷Toulouse, France
Inselspital Bern
🇨🇭Bern, Switzerland
USZ Zurich
🇨🇭Zürich, Switzerland
Rikshospitalet, Oslo University Hospital (OUS)
🇳🇴Oslo, Norway
St Thomas' Hospital - London
🇬🇧London, United Kingdom
Heart Center of the University Medical Center Mainz
🇩🇪Mainz, Germany
Royal Brompton Hospital
🇬🇧London, United Kingdom