Actively Recruiting
SQ-Kyrin TMVr FIM Study
Led by Shanghai Shenqi Medical Technology Co., Ltd · Updated on 2021-09-10
20
Participants Needed
1
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A feasibility study to evaluate the effectiveness and safety of the SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System for the treatment of moderate-to-severe mitral regurgitation in patients with high surgical risk.
CONDITIONS
Official Title
SQ-Kyrin TMVr FIM Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe mitral valve regurgitation grade 3 or higher
- High or prohibitive risk for conventional open thoracic surgery as defined by STS risk score or specific surgical risk factors
- Degenerated or functional mitral regurgitation patients who have received guideline-directed medical therapy
- Age 18 years or older, male or female
- Assessed as extremely high risk or unsuitable for conventional mitral valve surgery by a multidisciplinary heart team
- Anatomically suitable for transcatheter mitral valve repair with the SQ-Kyrin device
- Able to understand study objectives, volunteer, sign informed consent, and agree to examinations and follow-up
You will not qualify if you...
- History of cardiac and mitral valve surgeries
- Infective endocarditis or active infection
- Mitral valve stenosis
- Severe uncontrolled coronary artery disease
- Pulmonary artery hypertension with systolic pressure over 70 mmHg
- Severe right heart failure
- Left ventricular ejection fraction less than 30%
- New York Heart Association (NYHA) Class IV cardiac function
- Extremely weak patients unable to tolerate surgery under general anesthesia or in shock requiring circulatory support
- Hypertrophic, restrictive cardiomyopathy, or constrictive pericarditis
- Chronic dialysis
- Severe coagulation disorders or contraindications to anticoagulants
- Stroke or transient ischemic attack within past 30 days
- Any cardiac mass or thrombosis detected by echocardiography
- Other valve diseases needing surgery or intervention
- Severe macrovascular disease requiring surgery
- Untreated carotid artery stenosis over 70%
- Inappropriate cardiac or valve anatomy by imaging
- Known allergy to contrast media or nickel-titanium alloy
- Severe nervous system disorders affecting cognition
- Life expectancy less than 12 months
- Severe chest deformity
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
General Hospital of Northern Theater Command, PLA
Shenyang, Liaoning, China, 123005
Actively Recruiting
Research Team
G
Grace Gu
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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