About this trial
To observe and evaluate the safety and efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation through a prospective, multicenter clinical trial using objective performance criteria.
Eligibility criteria
Qualifiers
Patients who volunteer to participate and sign an informed consent form, understand the purpose of the clinical trial and are able to cooperate throughout the trial process;
An age ≥ 18 years;
Diagnostic transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days to determine the presence of symptomatic moderate-severe or severe degenerative mitral regurgitation (defined as mitral regurgitation grade ≥3+);
Patients' New York Heart Association (NYHA) cardiac function classification (see Appendix II) in grades II, III, or non-ambulatory grade IV;
Disqualifiers
The presence of intra-cardiac space occupancy, thrombus, or bulky organisms as indicated by echocardiography;
The presence of other severe heart valve diseases requiring surgical intervention;
inability of the valve clips to hold sufficient active leaflets;
lack of primary and secondary tendon support in the clamping area;
Trial design
Treatments tested in this trial
- GeminiOne Transcatheter Valve Edge-to-Edge Repair System