Safety and Effectiveness Study of SQ-Kyrin System for Functional Mitral Regurgitation in EU

Launched by SHANGHAI SHENQI MEDICAL TECHNOLOGY CO., LTD · Feb 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new device called the Transcatheter Mitral Valve Clip Delivery System, used to treat a condition known as functional mitral regurgitation (FMR). FMR occurs when the heart's mitral valve doesn’t close properly, leading to blood leaking backward into the heart. The trial is currently recruiting participants aged 18 and older who have been diagnosed with moderate to severe FMR and are experiencing symptoms despite taking heart failure medications.

To be eligible, patients should have a specific level of heart function and structure, as determined by tests like echocardiography. Participants in this study can expect to receive the new device and be closely monitored for its effects on their condition. It’s important to note that there are several criteria that could disqualify potential participants, including severe heart conditions or the need for other urgent treatments. Overall, this trial aims to explore a new option for patients who are at high risk for traditional heart surgery.

Gender

ALL

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.