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
1 other identifier
interventional
15
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2025
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2025
CompletedFirst Posted
Study publicly available on registry
April 30, 2025
CompletedStudy Start
First participant enrolled
September 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
January 7, 2026
January 1, 2026
1.1 years
April 4, 2025
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Secondary Endpoint: Performance Endpoint
30 days
Other Outcomes (1)
Additional Endpoints
6 months and 1 year
Study Arms (1)
prospective, single arm, open trial to evaluate the safety, functionality of the AMEND TS System
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patient age \>21
- 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
- Symptomatic functional MR≥3+
- NYHA functional capacity ≥2
- LV Ejection Fraction \> 30%, LVEDD \< 68 mm
- The subject meets the anatomical eligibility criteria for available implant size(s)
- The subject is at high risk for mitral valve surgery as assessed by the center's heart team for mitral procedures.
- Femoral vein access and transseptal device access is determined to be feasible by the implanting investigator
- The patient is willing to comply with study procedures and is available to return to the implant center for follow-up visits
- 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.
You may not qualify if:
- The patient has mitral incompetence where an annuloplasty ring will not contribute to its repair
- Cardiac or non-cardiac major or progressive disease, which in the investigator's discretion produces an unacceptable increased risk to the patient.
- Life expectancy of less than 12 months
- The subject is non-operable and is not eligible for TEER, to allow bailout
- Heavily calcified mitral annulus or leaflets
- Previous or active endocarditis.
- Active infection
- A previously implanted prosthetic aortic valve or mitral intervention
- Cardiovascular intervention within 30 days prior to study procedure
- GFR \<30 ml/min
- The patient has had an ischemic coronary event within 30 days prior to study procedure
- The patient has clinically significant coronary artery disease requiring re- vascularization
- The subject is contraindicated to general anesthesia
- The subject is unable to take anti-platelet or anti-coagulant medications
- A known allergy to nickel
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Banner University Medical Center - Phoenix
Phoenix, Arizona, 85006, United States
Scripps Health
La Jolla, California, 92037, United States
Piedmont Healthcare
Atlanta, Georgia, 30309, United States
Ascension St. Vincent
Indianapolis, Indiana, 46260, United States
Columbia University Medical Center (CUMC)
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239, United States
Saint Thomas Research Institute
Nashville, Tennessee, 37205, United States
University of Texas Health Science Center (UTH)
Houston, Texas, 77030, United States
Methodist Hospital HCA
San Antonio, Texas, 78229, United States
Intermountain Health
Murray, Utah, 84107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. David Meerkin, CMO, MD
Valcare Medical
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2025
First Posted
April 30, 2025
Study Start
September 11, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
January 7, 2026
Record last verified: 2026-01