Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation (NCT05988450) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation
China125 participantsStarted 2022-03-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
Exclusion criteria
✕. History of mitral valve surgery;
What they're measuring
1
Rate of all-cause death and hospitalization for heart failure
Timeframe: 12 months
Trial details
NCT IDNCT05988450
SponsorShanghai Shenqi Medical Technology Co., Ltd