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Clinical Trials in China / NCT05040074
Recruiting Not applicable

SQ-Kyrin TMVr FIM Study

NCT05040074 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Shenqi Medical Technology Co., Ltd
Phase
Not applicable
Started
2021-04-01
Last updated
2021-09-10

Condition(s) studied

Mitral Regurgitation

Investigational drug(s) / intervention(s)

SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System

SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System: Transesophageal echocardiography-guided, implantable mitral valve clip repair system

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Severe mitral valve regurgitation ≥ 3+ (moderate-to-severe mitral regurgitation disease); 2. Patients with high or prohibitive risk for conventional open thoracic surgery as defined by STS risk scoring result; subjects who are judged as not tolerating mitral valve surgery due to STS procedural mortality risk ≥ 8% for mitral valve replacement or presence of any of the following risk factors: 1. Porcelain aorta or active ascending aortic atheroma 2. Prior radiation therapy to mediastinum 3. History of mediastinitis 4. Left ventricular ejection fraction (LVEF) \< 40% 5. Presence of unobstructed coronary artery bypass graft 6. History of 2 or more cardiothoracic surgeries 7. Liver cirrhosis 8. Other surgical risk factors 3. Degenerated MR patients, or functional MR patients who have received guideline-directed medical therapy (GDMT therapy) 4. Age ≥ 18 years, male or female; 5. Patients who are at extremely high risk or not suitable for conventional mitral valve surgery, as assessed by a multidisciplinary heart team (including at least one cardiac surgeon and one cardiologist); 6. Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique and can be treated by the SQ-Kyrin device; 7. Patients who can understand the objectives of the trial, volunteer to participate in the study, sign the informed consent form, and are willing to receive related examinations and clinical follow-up. Exclusion Criteria: 1. History of cardiac and mitral valve surgeries; 2. Infective endocarditis or evidence of active infection; 3. Mitral valve stenosis; 4. Severe uncontrolled coronary artery disease; 5. Pulmonary artery hypertension (systolic pulmonary artery pressure \> 70 mmHg); 6. Severe right cardiac insufficiency; 7. LVEF \< 30%; 8. Cardiac function of NYHA Class IV; 9. Patient is extremely week to tolerate surgery under general anesthesia, or in a shock state indicating circulatory support; 10. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis; 11. Chronic dialysis; 12. Definite coagulation disorder and severe coagulation system diseases; 13. Clear contraindications for use of anticoagulants; 14. Cerebral stroke or transient ischemic attack in the past 30 days; 15. Any cardiac mass, left ventricular or atrial thrombosis identified by echocardiography; 16. Other valve diseases that requiring surgery or intervention; 17. Severe macrovascular disease requiring surgical treatment; 18. Treatment-naive carotid artery stenosis \> 70%; 19. Imaging evidence of inappropriate cardiac and valve anatomy; 20. Known hypersensitivity to contrast media, and nickel-titanium memory alloy products; 21. Severe nervous system disorder compromising the cognitive ability; 22. Life expectancy \< 12 months; 23. Severe thorax deformity; 24. Pregnant and lactating women.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
General Hospital of Northern Theater Command, PLA Shenyang Liaoning Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05040074 on ClinicalTrials.gov ↗ ← All trials in China