A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in Patients With Moderate-severe or Severe Functional MR (FMR)

Shanghai Shenqi Medical Technology Co., Ltd1 site in 1 country125 target enrollmentMarch 7, 2022

ConditionsFunctional Mitral Regurgitation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Functional Mitral Regurgitation
Sponsor: Shanghai Shenqi Medical Technology Co., Ltd
Enrollment: 125
Locations: 1
Primary Endpoint: Rate of all-cause death and hospitalization for heart failure
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

March 7, 2022

End Date

December 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Shenqi Medical Technology Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Severe functional MR (FMR) ≥3+ as determined by transthoracic echocardiography (TTE);
•Note: Eligible TTE must be obtained at least 30 days after the subject has been stabilized on optimal therapy (including Guideline Directed Medical Therapy GDMT). In the judgment of the center's cardiac team, subjects have received adequate treatment according to applicable criteria, including treatment for coronary artery disease, left ventricular dysfunction, MR, and heart failure (e.g., with cardiac resynchronization therapy (CRT or CRT-D), implantable cardioverter-defibrillator (ICD) implantation, coronary revascularization, and stable GDMT (see Appendix III for the definition of GDMT).
•Age ≥ 18 years old, regardless of gender;
•Cardiac function classification NYHA class II, III or ambulatory IV a;
•At least one hospitalization for heart failure or subjects with high BNP \> 150 pg/ml or high NT-proBNP \> 600 pg/ml in the past 12 months.
•Note: BNP or NT-proBNP must be obtained after the subject has stabilized on optimal therapy including Guideline Directed Medical Therapy (GDMT) at least 30 days. The patients can understand the purpose of the trial, voluntarily participate and sign an informed consent form, and are willing to undergo relevant tests and clinical follow-up.
•Left ventricular end-systolic diameter (LVESD)≤70mm
•The MR beam mainly originates from the A2/P2 area
•Mitral valve coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets\>10mm
•Mitral valve effective orifice area (EOA) ≥ 4.0cm2

Exclusion Criteria

•History of mitral valve surgery;
•Patients with infective endocarditis or suggestive of active infection;
•Complicated with severe untreated coronary artery disease;
•Patients with pulmonary hypertension (pulmonary systolic blood pressure\>70mmHg);
•patients with transthoracic echocardiographic evidence of moderate-severe to severe right ventricular dysfunction;
•Left heart ejection fraction \<20%;
•Patients who are extremely frail and cannot tolerate general anesthesia surgery or is in the state of shock requiring circulatory support;
•Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
•Severe renal insufficiency (eGFR ≤ 25 mL/min) or requiring chronic renal replacement therapy;
•Patients with definite coagulation disorders and severe coagulation system diseases;

Outcomes

Primary Outcomes

Rate of all-cause death and hospitalization for heart failure

Time Frame: 12 months

Freefrom of all-cause death and hospitalization for heart failure

Secondary Outcomes

Device success rate(30 days after surgery)
Rate of hospitalization for heart failure at 30 days, 6 months, and 12 months after surgery;(30 days, 6 months, and 12 months after surgery)
Technical success rate(Immediate postoperative)
The rate of NYHA heart function class I or II at 30 days, 6 months, and 12 months after surgery;(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);(12 months after surgery)
Surgical success rate(30 days after surgery)
Rate of MR 2+ or less than 2+ at 30 days, 6 months, and 12 months after surgery;(30 days, 6 months, and 12 months after surgery)
Improvement in 6-minute walk distance from baseline at 12 months after surgery;(12 months after surgery)
Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;(12 months after surgery)