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.
The primary objective is to verify the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. In the treatment of patients with moderate-severe (3 +) or severe (4 +) FMR whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
To 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.
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain
RECRUITINGNumber 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
Time frame: 12 months
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.
Time frame: immediately after intervention
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.
Time frame: 30 days
Procedural success rate
Defined by following two conditions: 1\. Device success. 2. No major adverse events occurred.
Time frame: 30 days
The rate of New York Heart Association (NYHA) heart function class I or II
Time frame: On the day of discharge, 30 days, 6 months, and 12 months
Improvement in quality of life from baseline
Improvement in quality of life (QoL) at 12 months over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score, scale from 0 - 100, and higher scores mean a better outcome.
Time frame: 12 months
Rate of MR 2+ or less than 2+
Mitral regurgitation severity grade 2+ or less than 2+
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Time frame: 30 days, 6 months, and 12 months
Change from baseline to discharge in MR severity assessed by echocardiography.
Time frame: On the day of discharge
Rate of hospitalization for heart failure
Time frame: 30 days, 6 months, and 12 months
Improvement by ≥ 50m in 6-minute walk distance from baseline
Time frame: 12 months
Improvement in left ventricular end-diastolic volume (LVEDV) from baseline
Time frame: 12 months
Incidence of all-cause mortality
Time frame: 30 days, 6 months, and 12 months
Cardiovascular-related mortality
Time frame: 30 days, 6 months, and 12 months
Incidence of major adverse events
The major adverse event refers to the composite endpoint of death, stroke, myocardial infarction, and cardiovascular surgery due to device- or interventional-related adverse events that occurred since successful transfemoral vein puncture and establishment of atrial septal pathway.
Time frame: 30 days and 12 months