Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Not applicable

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

NCT06823700 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-12-17
Last updated
2025-02-12

Condition(s) studied

Functional Mitral Regurgitation

Investigational drug(s) / intervention(s)

SQ-Kyrin Transcatheter Mitral Valve Repair System

SQ-Kyrin Transcatheter Mitral Valve Repair System: To percutaneously repair the mitral valve via the femoral vein and atrial septum, offering a treatment for symptomatic functional mitral regurgitation through edge-to-edge valve clipping.

Study summary

The investigation objective of this study is to evaluate the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in the population of FMR patients and the accessories devices when used in conjunction with the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of patients with composite measures- All-cause death and recurrent hospitalizations due to heart failure — 12 months
    A composite of all-cause death and recurrent hospitalizations due to heart failure

Trial sites (1)

FacilityCityRegionStatus
Hospital Clínico Universitario de Valladolid Valladolid Valladolid Recruiting
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 NCT06823700 on ClinicalTrials.gov ↗ ← All trials in Spain