Actively Recruiting
Safety and Effectiveness Study of SQ-Kyrin System for Functional Mitral Regurgitation in EU
Led by Shanghai Shenqi Medical Technology Co., Ltd · Updated on 2025-02-12
34
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 has provided written informed consent
- Age 18 years or older
- Diagnosed with functional mitral regurgitation (FMR)
- Mitral regurgitation severity of 3+ or higher by echocardiography
- Left ventricular ejection fraction (LVEF) between 20% and 60%
- Symptoms classified as NYHA functional class II to IV despite stable, maximally tolerated guideline-directed medical therapy
- Adequate treatment for at least 30 days, preferably 90 days, as judged by cardiology team
- Meets anatomical criteria for FMR and mitral valve suitability
- Considered high or prohibitive risk for open heart surgery by cardiology and cardiovascular surgery teams
- Left ventricular end-systolic diameter (LVESD) 70 mm or less
- Mitral regurgitation mainly from A2/P2 area
- Mitral valve coaptation depth 11 mm or less, coaptation height 2 mm or more
- Effective length of anterior and posterior leaflets more than 10 mm
- Mitral valve effective orifice area (EOA) 4.0 cm2 or more
- No significant calcification of main mitral valve leaflets
- Anatomy allows atrial septum approach
You will not qualify if you...
- Life expectancy less than 1 year due to non-cardiac conditions or heart failure suitable for palliative care
- Low blood pressure (systolic <90 mm Hg) or need for inotropic or mechanical support
- Status 1 heart transplant candidate or prior heart transplantation
- Structural heart diseases other than dilated cardiomyopathy causing heart failure
- Fixed pulmonary artery systolic pressure above 70 mm Hg
- Moderate or severe right ventricular dysfunction with signs of right-sided heart failure
- Mitral valve anatomy unsuitable for device treatment
- Mitral valve area less than 4.0 cm2 if device may reduce it further
- Prior mitral valve surgery or transcatheter mitral valve procedure
- Stroke or transient ischemic attack within 30 days before enrollment
- Modified Rankin Scale 4 or higher disability
- Severe symptomatic carotid stenosis over 70%
- Need for urgent or planned cardiac interventions within 12 months
- Recent implantation or revision of cardiac rhythm management devices within 1 month
- Untreated coronary artery disease requiring revascularization
- Cardiovascular or carotid interventions within 30 days
- Tricuspid valve disease requiring intervention or severe regurgitation
- Aortic valve disease requiring intervention
- Need for cardiovascular interventions other than mitral valve disease
- Intracardiac mass, thrombus, or vegetation seen on echocardiogram
- Active endocarditis or infections requiring antibiotics
- Contraindication or high risk for transesophageal echocardiography
- Conditions unlikely to allow completion of study procedures or follow-up
- Unable or unwilling to provide informed consent
- Pregnancy or planning pregnancy
- Severe liver, kidney, or lung disease affecting safety
- Significant lab abnormalities affecting safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain, 47003
Actively Recruiting
Research Team
C
Clinical Director
CONTACT
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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