The investigation objective of this study is to evaluate the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in the population of FMR patients and the accessories devices when used in conjunction with the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter.
Participant who has provided written informed consent for the investigation.
Age ≥18 years.
Patients diagnosed with FMR.
MR severity is (functional) ≥3+ as determined by transthoracic echocardiography (TTE).
Life expectancy <1 year due to non-cardiac conditions or heart failure deemed suitable for palliative treatment.
Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support.
UNOS status 1 heart transplantation or prior orthotopic heart transplantation.
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
Single group
SQ-Kyrin Transcatheter Mitral Valve Repair System
DeviceTo percutaneously repair the mitral valve via the femoral vein and atrial septum, offering a treatment for symptomatic functional mitral regurgitation through edge-to-edge valve clipping.
Number of patients with composite measures- All-cause death and recurrent hospitalizations due to heart failure
A composite of all-cause death and recurrent hospitalizations due to heart failure
Technical success rate
Defined by the following four conditions: 1\. No procedural mortality. 2. Successful delivery, implant, retrieval of the delivery system. 3. Successful devices release. 4. No need for any emergency surgery related to the device or surgical approach.
Device success rate
Defined by the following three conditions: 1\. Technical success maintained at day 30. 2. Transthoracic echocardiographic assessment showing MR ≤2+ without significant mitral stenosis. 3. No structural or functional failure of the device.
Procedural success rate
Defined by following two conditions: 1\. Device success. 2. No major adverse events occurred.
The rate of New York Heart Association (NYHA) heart function class I or II
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