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.
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；
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;
Single group
GeminiOne Transcatheter Valve Edge-to-Edge Repair System
DeviceThe transcatheter valve clamp system consists of a valve clamp, an adjustable bend mid-tube, and a manipulated inner tube. The adjustable bend introducer catheter consists of an adjustable bend outer tube and dilator. The valve clip is composed of nickel-titanium alloy, cobalt-chromium-nickel-molybdenum-iron alloy, and polyethylene terephthalate material and contains a closure clip, gripping tab, central mechanism, braid, and suture. The adjustable bend guiding catheter is used to provide access to the transcatheter valve clamping system and to reach the designated position. The adjustable curved mid-tube and manipulated inner tube are used to enable the delivery, gripping, and release process of the valve clips within the body.
Treatment success
Percentage of patients freedom from: death, surgery for valve dysfunction, and MR \> 2+ (moderate to severe (3+) or severe (4+) mitral regurgitation) .
Acute procedural success
Successful in GeminiOne implantation, and residual MR of 2+ or less at discharge. An echocardiography echocardiogram at 30 days can be accepted if the discharge image is not available or hard to interpret. A death before discharge or a re-operation of the mitral valve prior to 30 days is defined as acute procedure failure.
Acute device success
Rate of successful delivery and release of one or more GeminiOne devices with echocardiographic confirmation of leaflet clamping and successful withdrawal of the delivery catheter
Composite of function and re-operation measures
Number of patients freedom from postoperative surgery for mitral valve dysfunction.
Cardiac function change
Number of patients with New York Heart Association (NYHA) Function Class I or II.
Incidence of major adverse events (MAEs)
MAE is defined as a combined clinical endpoint of death, stroke, myocardial infarction, renal failure, and nonelective cardiovascular surgery for device or procedure-related adverse events occurring after transseptal catheterization.
All-cause mortality
The percentage of all-cause death includes cardiac death, non-cardiac death, and death from unknown causes.
Cardiac mortality
The percentage of cardiac death
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