Actively Recruiting
Safety and Effectiveness Study of Shenqi Transcatheter Mitral Valve Clips Delivery System and Steerable Guide Catheters in Patients with Functional Mitral Regurgitation
Led by Shanghai Shenqi Medical Technology Co., Ltd · Updated on 2025-02-12
34
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in patients with moderate to severe functional mitral regurgitation (FMR). This condition persists despite maximum tolerated guideline-directed medical therapy, and patients are selected based on specific heart function and valve characteristics. The study is sponsored by Shanghai Shenqi Medical Technology Co., Ltd and aims to assess these devices in treating FMR symptoms and valve issues. The study involves using the SQ-Kyrin Transcatheter Mitral Valve Repair System, which repairs the mitral valve through a minimally invasive approach via the femoral vein and atrial septum by clipping the valve edges together. This device is designed for patients with symptomatic FMR to improve valve function. The trial is a single-arm, prospective, multicenter study without masking or placebo control. Participants will be monitored over 12 months with assessments including mortality, hospitalizations for heart failure, heart function class changes, mitral regurgitation severity, quality of life, exercise capacity via a 6-minute walk test, and heart structure changes. Evaluations will involve echocardiography and other clinical measures at specified time points such as immediately after intervention, at 30 days, 6 months, and 12 months. Safety and procedural success rates will also be tracked throughout the study period.
CONDITIONS
Brief Title
Safety and Effectiveness Study of SQ-Kyrin System for Functional Mitral Regurgitation in EU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant who has provided written informed consent for the investigation.
- Age 18 years or older.
- Diagnosed with functional mitral regurgitation.
- Mitral regurgitation severity of 3+ or higher as determined by transthoracic echocardiography.
- Left ventricular ejection fraction between 20% and 60%.
- New York Heart Association (NYHA) functional class II to IV despite stable, maximally tolerated guideline-directed medical therapy.
- Has undergone adequate treatment for at least 30 days, preferably 90 days, based on heart failure guidelines.
- Meets functional mitral regurgitation anatomy selection criteria.
- Deemed high or prohibitive risk for open heart surgery by local cardiovascular medical-surgery team.
- Left ventricular end-systolic diameter of 70 mm or less.
- Mitral regurgitation mainly from the A2/P2 area.
- Mitral valve coaptation depth 11 mm or less, coaptation height 2 mm or more, and effective length of anterior and posterior leaflets greater than 10 mm.
- Mitral valve effective orifice area of 4.0 cm2 or more.
- No significant calcification of main grasp mitral valve leaflets.
- Anatomy allows atrial septum approach.
You will not qualify if you...
- Life expectancy under 1 year due to non-cardiac conditions or heart failure suitable for palliative treatment.
- Low blood pressure (systolic pressure under 90 mm Hg) or need for inotropic or mechanical hemodynamic support.
- Heart transplantation listed as UNOS status 1 or prior heart transplantation.
- Other cardiac diseases causing heart failure such as hypertrophic or restrictive cardiomyopathy, constrictive pericarditis.
- Pulmonary artery systolic pressure above 70 mm Hg.
- Moderate or severe right ventricular dysfunction with signs of right-sided congestive heart failure.
- Mitral valve anatomy unsuitable for device treatment.
- Mitral valve area less than 4.0 cm2.
- Previous mitral valve surgery or transcatheter mitral valve procedure.
- Stroke or transient ischemic attack within 30 days before enrollment.
- Severe disability (Modified Rankin Scale 4 or higher).
- Severe symptomatic carotid artery narrowing greater than 70%.
- Need for urgent or planned cardiac intervention within 12 months.
- Recent implant or revision of cardiac rhythm management devices within 1 month.
- Untreated significant coronary artery disease requiring revascularization.
- Cardiovascular or carotid interventions within 30 days.
- Tricuspid valve disease needing intervention or severe tricuspid regurgitation.
- Aortic valve disease requiring intervention or other concomitant treatments.
- Echocardiographic evidence of intracardiac masses, thrombus, or infection.
- Active infections requiring antibiotics.
- Contraindication or high risk for transesophageal echocardiography.
- Conditions preventing completion of protocol procedures or follow-up.
- Unable or unwilling to provide informed consent.
- Pregnant or planning pregnancy.
- Severe liver, kidney, or lung disease affecting safety.
- Significant lab abnormalities impacting safety.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-procedure period
Participants receive the SQ-Kyrin Transcatheter Mitral Valve Repair System via a minimally invasive procedure to repair the mitral valve and treat functional mitral regurgitation.
1 procedure visit and monitoring until discharge
Duration - Up to 12 months
Participants are monitored for safety and effectiveness of the device after the procedure, including assessments of heart function and mitral regurgitation severity.
Visits on the day of discharge, 30 days, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain, 47003
Actively Recruiting
Research Team
C
Clinical Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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