AMEND TS Early Feasibility Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Symptomatic Functional MR 3 or Greater
• Intervention / Treatment: Device: This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.

Detailed Description

Objective: The purpose of this clinical investigation, the AMEND TS Early Feasibility Study, is to evaluate the safety and functionality of the AMEND Trans-Septal System for annuloplasty as treatment of mitral regurgitation.

Device Description: The AMENDTM Trans-Septal System consists of a semi-rigid annuloplasty ring (implant), a delivery system (catheter), and accessories (Stage, Introducer sheath). The device is delivered through a catheter using a trans-septal approach and implanted in the beating heart on the atrial surface of the mitral valve annulus similar to surgical annuloplasty rings.

Indications for Use: The device is indicated to treat patients with mitral regurgitation using a percutaneous direct annuloplasty approach

Number of subjects and sites: Up to fifteen (15) subjects will be enrolled to the study procedure in up to 7 investigational centers in the U.S. and Canada

Study Population: Subjects with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation that is anatomically amenable to transcatheter mitral annuloplasty.

Study Duration: 5 years

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anat Eitan, VP RA & Clinical; Phone Number: +972546280106; Email: aeitan@valcaremedical.com
• Study Contact Backup: Name: Madhuri Bhat; Phone Number: 408-230-2442; Email: mbhat@valcaremedical.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • Banner University Medical Center - Phoenix
      • Principal Investigator: Paul Sorajja, MD
      • Contact: Karen Moylen; Email: kmoylen@arizona.edu
  • California
    • La Jolla, California, United States, 92037
      • Not yet recruiting
      • Scripps Health
      • Contact: Crystal Serneo; Email: Serneo.Crystal@scrippshealth.org
      • Principal Investigator: Matthew Price, MD, FACC
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Not yet recruiting
      • Piedmont Healthcare
      • Principal Investigator: Pradeep Yadav, MD
      • Contact: Caryn Bernstein; Email: Caryn.Bernstein@piedmont.org
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Ascension St. Vincent
      • Contact: Jena Stanley; Email: jena.stanley@ascension.org
      • Principal Investigator: James Hermiller, MD, FACC
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center (CUMC)
      • Principal Investigator: Susheel Kodali, MD
      • Contact: Krystal Garcia; Email: kg3016@cumc.columbia.edu
    • The Bronx, New York, United States, 10467
      • Not yet recruiting
      • Montefiore Medical Center
      • Principal Investigator: Mohamed Azeem Latib, MD
      • Contact: Tammy Rodriguez Guzman; Email: tamrodrigu@montefiore.org
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University (OHSU)
      • Principal Investigator: Firas Zahr, MD
      • Contact: Ashtyn Chamberland; Email: chamasht@ohsu.edu
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Not yet recruiting
      • Saint Thomas Research Institute
      • Contact: Emily Normandin; Email: emily.normandin@ascension.org
      • Principal Investigator: Evelio Rodriguez, MD, FACC
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas Health Science Center (UTH)
      • Contact: Anna Meneres; Email: anna.m.menezes@uth.tmc.edu
      • Principal Investigator: Abhijeet Dhoble, MBBS, MPH, RPVI, FACP, FACC
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Methodist Hospital HCA
      • Principal Investigator: Jorge Alvarez, MD
      • Contact: Jaymee Lopez; Email: Jaymee.Lopez@hcahealthcare.com
  • Utah
    • Murray, Utah, United States, 84107
      • Not yet recruiting
      • Intermountain Health
      • Contact: Erika Hummel; Email: erika.hummel@imail.org
      • Principal Investigator: Brian Whisenant, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: prospective, single arm, open trial to evaluate the safety, functionality of the AMEND TS System; The AMEND TS EFS is a prospective, single arm, open clinical trial designed to evaluate the safety and functionality of the AMENDTM Trans-Septal System for MR reduction in patients suffering from functional mitral regurgitation. This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.

Device: This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.; The ability to deploy the annuloplasty ring in a percutaneous fashion affords an improved safety profile for surgical candidates, as well as surgical style solution for those patients that are at elevated risk for surgery due to comorbidities and advanced age. This early feasibility study allows treatment of higher risk surgical candidates with a surgical- level annuloplasty repair therapy by the AMEND™ Implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint: Composite of death (all-cause), stroke, myocardial infarction (MI), or non-elective cardiovascular surgery for device related complications at 30 days.	The definitions of the SAEs are based on the recommendation of the Mitral Valve Academic Research Consortium (MVARC) (Stone, 2015).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint: Performance Endpoint	Technical success of ring delivery, implantation and delivery system retrieval determined at the end of implantation procedure based on the following: Absence of procedural mortality; Freedom from emergency surgery or corrective treatment related to the device or access procedure; Successful access, delivery to the LA, and retrieval of the delivery system; Correct positioning of the implant evaluated by echocardiography after procedure completion; Adequate implant quadrant fixation evaluated by echocardiography after procedure completion	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional Endpoints	Safety at 6 months; a composite of all-cause death, stroke, MI, or non-elective cardiovascular surgery for device related complications	6 months and 1 year

Collaborators and Investigators

• Sponsor: Valcare Medical Ltd.
• Investigators: Study Director: Dr. David Meerkin, CMO, MD, Valcare Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: mitral regurgitation; Heart valve; mitral valve; functional mitral regurgitation; MR reduction; annuloplasty ring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: CIP - 0001762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes