This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR). The registry primarily focuses on patients treated with TMVR in real-world clinical practice. Patients evaluated for TMVR but not undergoing the procedure are no longer systematically included. Historical data may include such patients who subsequently underwent alternative treatments, including transcatheter edge-to-edge repair, mitral valve surgery, or medical/conservative therapy.
Study Type
OBSERVATIONAL
Enrollment
1,000
Tucson Medical Center
Tucson, Arizona, United States
RECRUITINGCedars-Sinai Medical Center, Los Angeles
Los Angeles, California, United States
RECRUITINGTampa General Hospital
Tampa, Florida, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGMinneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
RECRUITINGMorristown Medical Center
Morristown, New Jersey, United States
RECRUITINGMontefiore Medical Center
New York, New York, United States
RECRUITINGOklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
RECRUITINGHouston Methodist Hospital
Houston, Texas, United States
RECRUITINGSt Vincent's Hospital
Sydney, Australia
RECRUITING...and 33 more locations
Mitral insufficiency grade 2+ or more
Mitral insufficiency measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.
Time frame: 12 months
Freedom from device-related complications
Time frame: 30 days
Combined all-cause mortality or rehospitalization for congestive heart failure
Time frame: 12 months
All-cause mortality
Time frame: 12 months
Cardiovascular mortality
Time frame: 12 months
Rehospitalization for congestive heart failure
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.
Time frame: 12 months
Combined cardiovascular mortality or rehospitalization for congestive heart failure
Time frame: 12 months
Unplanned mitral valve intervention
Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or left ventricular assist device implantation, e.g. as assessed by patient interviews.
Time frame: 12 months
Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention
Time frame: 12 months
Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention
Time frame: 12 months
New York Heart Association (NYHA) stage III or IV
Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient) after 12 months follow-up, as assessed by patient interviews.
Time frame: 12 months
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