Mitral regurgitation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Moderate to severe (grade 3) or severe (grade 4) chronic mitral valve regurgitation; not a candidate for mitral valve surgery (patient declined surgery or the operation has been turned down by surgeon) andsymptomatic with LVEF > 25% and LVIDs 50mmHg at rest or >60mmHg with exercise
Exclusion criteria
Exclusion criteria: 1. Patients not able to give informed consent; 2. Patients cannot tolerate transesophageal echocardiogram; 3. Patients with advanced chronic kidney disease with serum creatinine of greater than 2mg/dl or end stage renal disease; 4. Patients who has intracardiac thrombus detected by TEE; 5. Mitral valvular area assessed by echocardiography less than 4cm2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute procedure success (defined as reduction of MR to 2+) immediately after implantation;A composite of adverse events including death, major stroke, reoperation 1 month after procedure;A composite of adverse events including urgent/emergent surgery 1 month after procedure;A composite of adverse events including myocardial infarction, renal failure 1 month after procedure;A composite of adverse events including the need for blood transfusion 1 month after procedure; | — |
Countries
China