RecruitingNCT06951672
AMEND TS Early Feasibility Study
AI Description
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.
- Who can join
- adult, older adult
- Participants
- 15
- Expected completion
- 2027-04
- Funded by
- industry
Conditions studied
Symptomatic Functional MR 3 or Greater
What is being tested
- DEVICE: This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.
What it measures
- 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
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Ascension Saint Thomas Hospital
Nashville, TN
Banner – University Medical Center Phoenix
Phoenix, AZ
Intermountain Medical Center
Murray, UT
Methodist Hospital
San Antonio, TX
Montefiore Einstein Hospital (Moses Campus)
Bronx, NY
OHSU Hospital
Portland, OR
Piedmont Atlanta Hospital
Atlanta, GA
Scripps Memorial Hospital La Jolla
La Jolla, CA
Registry entry updated 2026-01-07
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.