| NCT ID | NCT06951672 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Valcare Medical Ltd. |
| Condition | Symptomatic Functional MR 3 or Greater |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-09-11 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-09-11 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments.
Eligibility Criteria
Inclusion Criteria: 1. Patient age \>21 2. The patient will benefit from isolated mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical procedures such as coronary artery bypass or another valve reconstruction or replacement 3. Symptomatic functional MR≥3+ 4. NYHA functional capacity ≥2 5. LV Ejection Fraction \> 30%, LVEDD \< 68 mm 6. The subject meets the anatomical eligibility criteria for available implant size(s) 7. The subject is at high risk for mitral valve surgery as assessed by the center's heart team for mitral procedures. 8. The subject has been stable and on a stable pharmacological regimen for heart failure for at least 1 month prior to inclusion 9. Femoral vein access and transseptal device access is determined to be feasible by the implanting investigator 10. The patient is willing to comply with study procedures and is available to return to the implant center for follow-up visits 11. Informed consent documentation signed and dated confirming that the patient has been adequately informed of all aspects related to his/her participation in the clinical study and is willing to participate. Exclusion Criteria: 1. The patient has mitral incompetence where an annuloplasty ring will not contribute to its repair 2. Cardiac or non-cardiac major or progressive disease, which in the investigator's discretion produces an unacceptable increased risk to the patient. 3. Life expectancy of less than 12 months 4. The subject is non-operable and is not eligible for TEER, to allow bailout 5. Heavily calcified mitral annulus or leaflets 6. Previous or active endocarditis. 7. Active infection 8. A previously implanted prosthetic aortic valve or mitral intervention 9. Cardiovascular intervention within 30 days prior to study procedure 10. GFR \<30 ml/min 11. The patient has had an ischemic coronary event within 30 days prior to study procedure 12. The patient has clinically significant coronary artery disease requiring re- vascularization 13. The subject is contraindicated to general anesthesia 14. The subject is unable to take anti-platelet or anti-coagulant medications 15. A known allergy to nickel 16. Severe allergy to contrast media 17. Significant right ventricle dysfunction 18. Left atrial thrombus 19. A cerebral vascular event (CVA or TIA) within the past 12 months 20. A mitral valve anatomy which may preclude proper AMEND™ treatment 21. Pulmonary systolic hypertension (estimated SPAP \> 70 mmHg at rest), determined by echocardiography 22. Pregnant (for women in the reproductive age, blood HCG test result positive) or lactating patient 23. Drug or alcohol abuse 24. Participation in concomitant research studies of investigational products 25. Any planned cardiac surgery or interventions within the next 7 months 26. Implant or revision of any rhythm management device (cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy device (CRT-D)) or implantable cardioverter defibrillator within the prior month 27. Hypotension (systolic pressure \<90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support 28. Status 1 heart transplantation or prior orthotopic heart transplantation 29. Subjects in whom transesophageal echocardiography is contraindicated or high risk
Contact & Investigator
Dr. David Meerkin, CMO, MD
STUDY DIRECTOR
Valcare Medical
Frequently Asked Questions
Who can join the NCT06951672 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Symptomatic Functional MR 3 or Greater. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06951672 currently recruiting?
Yes, NCT06951672 is actively recruiting participants. Contact the research team at aeitan@valcaremedical.com for enrollment information.
Where is the NCT06951672 trial being conducted?
This trial is being conducted at Phoenix, United States, La Jolla, United States, Atlanta, United States, Indianapolis, United States and 7 additional locations.
Who is sponsoring the NCT06951672 clinical trial?
NCT06951672 is sponsored by Valcare Medical Ltd.. The principal investigator is Dr. David Meerkin, CMO, MD at Valcare Medical. The trial plans to enroll 15 participants.