The AMEND TS Early Feasibility Study is a Prospective, Single-arm, Multi-center Study to Evaluate the Safety and Function of the AMEND(TM) Trans-Septal System for MR Reduction: Up to 15 Subjects Will be Enrolled in up to 7 Investigational Centers in the U.S. and Canada With a 30d Safety Endpoint

Launched by VALCARE MEDICAL LTD. · Apr 22, 2025

Keywords

ClinConnect Summary

The AMEND TS Early Feasibility Study is looking at a new device called the AMEND™ Trans-Septal System, which is designed to help treat a heart condition known as mitral regurgitation. This condition occurs when the heart's mitral valve doesn't close properly, allowing blood to flow backward. The study will involve up to 15 participants from various centers in the U.S. and Canada, aiming to see how safe and effective this device is for patients who are at high risk for traditional surgical procedures.

To be eligible for this study, participants need to be over 21 years old and have significant symptoms related to mitral regurgitation. They should not require additional heart surgeries at the same time, and their heart function must be stable. If someone joins the study, they can expect to receive the AMEND™ device through a minimally invasive procedure, meaning it will be implanted using a thin tube (catheter) rather than through open surgery. This could offer a safer option for patients who are older or have other health issues. It's important for potential participants to discuss their specific situation with their healthcare team to understand the risks and benefits of joining this trial.

Gender

ALL

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 h1. 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 intervention 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