To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. in patients with moderate-severe (3 +) or severe (4 +) functional MR (functional MR) who still have symptoms after full treatment.
This study is a prospective, multi-center, single arm clinical study designed to evaluate the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter in patients with moderate-severe (3 +) or severe (4 +) functional MR (Functional MR) who still have symptoms after adequate treatment. This trial will be conducted at 41 sites in China and is planned to include a total of 118 subjects. All subjects received the trial device for transcatheter mitral valve clip delivery system and steerable guide catheter, and were followed up at 30 days, 6 months, and 12 months after surgery. The composite endpoint of all-cause death and hospitalization for heart failure was assessed at 12 months after surgery. After the 12th month follow-up, the statistical analysis, clinical summary and application for product registration were carried out.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Transcatheter mitral valve clip placement to repair the valve and correct regurgitation.
General Hospital of Northern Theater Command, PLA
Shenyang, Liaoning, China
Rate of all-cause death and hospitalization for heart failure
Freefrom of all-cause death and hospitalization for heart failure
Time frame: 12 months
Technical success rate
1. No surgical death 2. Delivery system for successful delivery and retrieval of devices 3. Successful devices release and accurate positioning 4. No need for any emergency surgery related to the device or surgical approach
Time frame: Immediate postoperative
Device success rate
1. Successfully implanted valve clip 2. Transthoracic echocardiographic assessment showing MR ≤2+
Time frame: 30 days after surgery
Surgical success rate
1. Device success 2. No major adverse events occurred The major adverse event refers to the composite endpoint of death, stroke, myocardial infarction, and cardiovascular surgery due to device- or surgery-related adverse events following the atrial septum pathway via the femoral vein.
Time frame: 30 days after surgery
Rate of MR 2+ or less than 2+ at 30 days, 6 months, and 12 months after surgery;
Rate of MR 2+ or less than 2+ at 30 days, 6 months, and 12 months after surgery;
Time frame: 30 days, 6 months, and 12 months after surgery
Rate of hospitalization for heart failure at 30 days, 6 months, and 12 months after surgery;
Rate of hospitalization for heart failure at 30 days, 6 months, and 12 months after surgery;
Time frame: 30 days, 6 months, and 12 months after surgery
The rate of NYHA heart function class I or II at 30 days, 6 months, and 12 months after surgery;
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The rate of NYHA heart function class I or II at 30 days, 6 months, and 12 months after surgery;
Time frame: 30 days, 6 months, and 12 months after surgery
Improvement in quality of life from baseline at 12 months after surgery (as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score);
Improvement in quality of life from baseline at 12 months after surgery (as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score);
Time frame: 12 months after surgery
Improvement in 6-minute walk distance from baseline at 12 months after surgery;
Improvement in 6-minute walk distance from baseline at 12 months after surgery;
Time frame: 12 months after surgery
Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;
Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;
Time frame: 12 months after surgery