Evaluation of a new valve repair system for severe mitral regurgitation

SQ-Kyrin Transcatheter Mitral Valve Repair System Feasibility Study

This study is testing a new valve repair system to see if it can safely help people with severe mitral regurgitation who are at high risk for surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Shenqi Medical Technology Co., Ltd (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT05040074 on ClinicalTrials.gov

What this trial studies

This feasibility study aims to assess the effectiveness and safety of the SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System in treating moderate-to-severe mitral regurgitation in patients deemed high surgical risk. It is a prospective, multicenter, single-arm observational study that will enroll between 10 to 30 patients. The primary endpoint is the immediate technical success rate post-operation, while secondary endpoints include all-cause mortality and serious adverse events within 30 days post-operation. Patients will be followed for up to 5 years to evaluate long-term outcomes.

Who should consider this trial

Good fit: Ideal candidates include patients with severe mitral valve regurgitation and high surgical risk, as determined by specific clinical criteria.

Not a fit: Patients who are not at high surgical risk or have mild mitral regurgitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with severe mitral regurgitation who are at high risk for traditional surgery.

How similar studies have performed: While similar approaches have been explored, this specific device and methodology are relatively novel and have not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Shenyang, Liaoning

• General Hospital of Northern Theater Command, PLA — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Study coordinator: Grace Gu

Conditions Mitral Regurgitation