AMEND Trans‑Septal System for mitral valve annuloplasty (early feasibility)

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

This will test a catheter-delivered AMEND Trans‑Septal annuloplasty ring to reduce moderate-to-severe functional mitral regurgitation in adults who are at high surgical risk.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Valcare Medical Ltd. (industry)
• Locations: 11 sites (Phoenix, Arizona and 10 other locations)
• Trial ID: NCT06951672 on ClinicalTrials.gov

What this trial studies

The AMEND Trans‑Septal System is a semi-rigid annuloplasty ring delivered via a catheter using a trans‑septal approach and implanted on the atrial surface of the mitral annulus in the beating heart. In this early feasibility study up to 15 adults with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation who are at high surgical risk will be treated at up to seven centers in the U.S. and Canada. Patients will be followed for safety and device functionality with clinical and imaging assessments over a five-year period. Key entry criteria include NYHA class II or greater, LVEF >30%, anatomic suitability for available implant sizes, and stability on heart failure medication.

Who should consider this trial

Good fit: Adults over 21 with symptomatic functional MR grade 3+ or 4+, NYHA class ≥II, LVEF >30%, anatomy suitable for the implant, and judged high risk for surgical mitral repair are the intended candidates.

Not a fit: Patients who need concomitant cardiac surgery, have primary degenerative (non-functional) MR, have LVEF ≤30%, or whose anatomy is not compatible with available implant sizes are unlikely to benefit.

Why it matters

Potential benefit: If successful, the device could reduce mitral regurgitation and symptoms while providing a less invasive alternative for patients at high risk for open-heart surgery.

How similar studies have performed: Other transcatheter annuloplasty and transcatheter mitral repair approaches have demonstrated feasibility and symptomatic improvement in prior studies, but the AMEND Trans‑Septal System is being tested here in an early feasibility setting.

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

Where this trial is running

Phoenix, Arizona and 10 other locations

• Banner University Medical Center - Phoenix — Phoenix, Arizona, United States (RECRUITING)
• Scripps Health — La Jolla, California, United States (NOT_YET_RECRUITING)
• Piedmont Healthcare — Atlanta, Georgia, United States (NOT_YET_RECRUITING)
• Ascension St. Vincent — Indianapolis, Indiana, United States (RECRUITING)
• Columbia University Medical Center (CUMC) — New York, New York, United States (RECRUITING)
• Montefiore Medical Center — The Bronx, New York, United States (NOT_YET_RECRUITING)
• Oregon Health & Science University (OHSU) — Portland, Oregon, United States (RECRUITING)
• Saint Thomas Research Institute — Nashville, Tennessee, United States (NOT_YET_RECRUITING)
• University of Texas Health Science Center (UTH) — Houston, Texas, United States (RECRUITING)
• Methodist Hospital HCA — San Antonio, Texas, United States (RECRUITING)
• Intermountain Health — Murray, Utah, United States (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Anat Eitan, VP RA & Clinical

Conditions: Symptomatic Functional MR 3 or Greater, MR reduction, mitral regurgitation, Heart valve, annuloplasty ring, functional mitral regurgitation, mitral valve