SQ-Kyrin TMVr FIM Study

Incidence of acute procedural success

Must meet all the four items：1）no procedural mortality; 2）success in delivery and retrieval of the device delivery system; 3）successful deployment and accurate positioning of the device; 4）no emergency surgery or reintervention related to the device or surgical approach

All-cause mortality

Death from any cause

Incidence of serious adverse event(SAE)

If the adverse event meets any of the criteria below, it is regarded as a serious adverse event (SAE): 1) results in death; 2) is life threatening, results in illness or injury; 3) requires inpatient hospitalization or prolongation of existing hospitalization; 4) results in a persistent or significant disability/incapacity; 5) results in a congenital anomaly/birth defect, fetal death, fetal distress; 6) results in medical or surgical intervention to prevent permanent impairment to body structure or a body function; 7) an important medical event that may not result in death, be life-threatening, or require hospitalization but may be considered serious when, based upon appropriate medical judgment, may jeopardize the patient or subject and/or may require intervention to prevent one of the outcomes listed in this definition.

Device success rate

Definition of device success（must meet all the four items） ：1) No procedural mortality or stroke；2) Proper deployment and positioning of the device；3) No emergency surgery or reintervention related to the device or surgical approach；4) The implanted mitral valve repair system achieves the following safety and effectiveness indicators: * No evidence of structural or functional abnormality * No device-related technical failure or complication * Significant functional improvement after valve repair, without significant stenosis (post-op EOA ≥ 1.5 cm2 and transvalvular pressure gradient \< 5 mmHg/valve regurgitation ≤ Grade 2+/no device-related hemolysis)

Procedural success rate

Definition of procedural success（must meet the two items）：1) Device success；2) Absence of the following severe complications: death; stroke; life-threatening hemorrhage; severe vascular complications; secondary severe organic heart diseases (e.g.: aortic dissection, left atrium/auricle rupture, left ventricular outflow tract obstruction, etc.); Grade II-III and above renal insufficiency; myocardial infarction or coronary ischemia requiring percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); severe hypotension, heart failure, respiratory failure requiring use of high-dose vasoactive medications/mechanical acids; any valve-related dysfunctions, including repair device detachment (single or two valve leaflets)/embolism/device-related autologous mitral valve damage/other conditions requiring second intervention.