AMEND TS Early Feasibility Study for Mitral Regurgitation
This study is testing a new device called the AMEND™ Trans-Septal System. This system uses a special ring to help fix a leaky heart valve (mitral regurgitation) without open-heart surgery. It's designed for people with moderate to severe symptoms whose heart valve is leaking. The study wants to see how safe the AMEND™ system is and how well it works. To join, you must be over 21, have symptomatic functional mitral regurgitation of 3 or greater, and meet other heart health criteria. The main goal is to check for serious problems like death, stroke, or heart attack within 30 days after the procedure. The current recruitment status is unclear, and the study plans to enroll up to 15 participants.
- Study design
- This is an interventional study, meaning participants will receive the AMEND™ Trans-Septal System. Up to 15 people will be enrolled.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for at least 30 days after the procedure, and the overall study duration is 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
AMEND TS Early Feasibility Study
At a glance
Conditions
Where it's being run
11 sites across 9 statesStudy leadership
- Dr. David Meerkin, CMO, MD · STUDY_DIRECTOR · Valcare Medical
Who to contact
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What this trial measures
- Safety Endpoint: Composite of death (all-cause), stroke, myocardial infarction (MI), or non-elective cardiovascular surgery for device related complications at 30 days.30 days
The definitions of the SAEs are based on the recommendation of the Mitral Valve Academic Research Consortium (MVARC) (Stone, 2015).