Evaluating a new system for treating functional mitral regurgitation

A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Shenqi Transcatheter Mitral Valve Clips Delivery System and Steerable Guide Catheters in Patients with Functional Mitral Regurgitation

This study is testing a new device to see if it can safely help people with moderate to severe mitral regurgitation feel better when other treatments haven't worked.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Shenqi Medical Technology Co., Ltd (Industry-sponsored)
• Locations: 1 site (Valladolid, Valladolid)
• Trial ID: NCT06823700 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of the SQ-Kyrin Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in patients with moderate to severe functional mitral regurgitation (FMR). It focuses on individuals whose symptoms persist despite optimal medical therapy, as determined by a multidisciplinary heart team. The study will involve a thorough evaluation of the device's performance in a clinical setting, ensuring that it meets safety standards while providing effective treatment options for patients with FMR.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe functional mitral regurgitation who have not responded adequately to medical therapy.

Not a fit: Patients with mild mitral regurgitation or those who are not at high risk for open heart surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a less invasive treatment option for patients suffering from severe functional mitral regurgitation.

How similar studies have performed: Other studies have shown promising results with similar transcatheter approaches for mitral valve repair, indicating potential for success in this area.

Eligibility criteria

Inclusion Criteria:

1. Participant who has provided written informed consent for the investigation.
2. Age ≥18 years.
3. Patients diagnosed with FMR.
4. MR severity is (functional) ≥3+ as determined by transthoracic echocardiography (TTE).
5. LVEF ≥20% to ≤60%.
6. Symptom status: NYHA functional class II to IV despite a stable maximally tolerated GDMT regimen as per guidelines.
7. According to the judgment of local cardiology team, subjects have undergone adequate treatment for at least 30 days (preferably 90 days) based on the criteria recommended in the heart failure guidelines.
8. Subject fulfils FMR anatomy selection criteria.
9. According to the judgment of the local Cardiovascular medical-surgery team, subjects who have high or prohibitive risk for open heart surgery.
10. Left ventricular end-systolic diameter (LVESD)≤70mm.
11. The MR beam mainly originates from the A2/P2 area.
12. Mitral valve coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets\>10mm.
13. Mitral valve effective orifice area (EOA) ≥ 4.0cm2.
14. No obvious calcification of main grasp mitral valve leaflets.
15. Patient anatomy allows atrial septum approach.

Exclusion Criteria:

1. Life expectancy \<1 year due to non-cardiac conditions or heart failure deemed suitable for palliative treatment.
2. Hypotension (systolic pressure \<90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support.
3. UNOS status 1 heart transplantation or prior orthotopic heart transplantation.
4. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
5. Fixed pulmonary artery systolic pressure \>70 mm Hg.
6. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
7. Mitral valve anatomy which may preclude proper device treatment.
8. Mitral valve area \< 4.0 cm2 (if new device therapy may further decrease the mitral orifice area).
9. Any prior mitral valve surgery or transcatheter mitral valve procedure.
10. Stroke or transient ischemic event within 30 days before enrolment.
11. Modified Rankin ≥ Scale 4 disability.
12. Severe symptomatic carotid stenosis (\>70% by ultrasound).
13. Need for emergent or urgent intervention for any reason or any planned cardiac intervention within the next 12 months.
14. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within 1 month before enrolment.
15. Untreated clinically significant coronary artery disease requiring revascularization.
16. Any percutaneous cardiovascular intervention, cardiovascular intervention, or carotid intervention within 30 days
17. Tricuspid valve disease requiring intervention or severe or more tricuspid regurgitation.
18. Aortic valve disease requiring intervention or any concomitant treatment.
19. Need for any cardiovascular intervention (other than for MV disease).
20. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
21. Active endocarditis.
22. Active infections requiring current antibiotic therapy.
23. Subjects in whom transoesophageal echocardiography is contraindicated or high risk.
24. Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits.
25. Patient unable or unwilling to provide written, informed consent before study enrolment.
26. Pregnant woman or woman planning to become pregnant.
27. Patients with severe liver, renal or pulmonary disease, which in investigator opinion may have an impact on patient safety.
28. Clinically significant lab abnormalities which in investigator opinion may have an impact on patient safety.

Where this trial is running

Valladolid, Valladolid

• Hospital Clínico Universitario de Valladolid — Valladolid, Valladolid, Spain (Recruiting)

Study contacts

• Principal investigator: Ignacio J Amat-Santos, MD, Ph.D — Hospital Clínico Universitario de Valladolid
• Study coordinator: Clinical Director

Conditions Functional Mitral Regurgitation