Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients W… (NCT05655897) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation
China120 participantsStarted 2022-11-24
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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；
✓. Patients' left ventricular ejection fraction LVEF ≥ 20%;
✓. Patients considered to be at high surgical risk by the multidisciplinary cardiac team ;
✓. Patients are anatomically suitable for mitral valve repair and suitable for the device under this study as assessed by the multidisciplinary cardiac team;
✓. Mitral valve orifice area ≥ 4.0 cm2;
Exclusion criteria
✕. 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;
✕. Leaflet anatomy that may prevent implantation of the valve clip, proper positioning on the leaflet, or prevent adequate reduction of mitral regurgitation by the valve clip. The assessment is based on transesophageal echocardiographic (TEE) mitral valve evaluation within 180 days prior to the subject's registration and includes:
What they're measuring
1
Treatment success
Timeframe: 12 months
Trial details
NCT IDNCT05655897
SponsorPeijia Medical Technology (Suzhou) Co., Ltd.
✕. inability of the valve clips to hold sufficient active leaflets;
✕. lack of primary and secondary tendon support in the clamping area;
✕. significant evidence of calcification in the clamping area;
✕. significant fissures in the clamping area;
✕. Active endocarditis, pericarditis, or rheumatic heart disease; or mitral valve leaflet changes resulting from endocarditis or rheumatic heart disease;