Trisol System for Tricuspid Regurgitation
This study is testing the Trisol System, a device designed to replace the tricuspid valve (one of the heart's four valves) using a transcatheter approach (meaning it's inserted through a small tube, often in a blood vessel, rather than open-heart surgery). The goal is to learn about its safety and how well it performs in people with moderate or severe tricuspid regurgitation (TR), a condition where the tricuspid valve doesn't close properly, causing blood to leak backward. You might be able to join if you are over 18 and have symptomatic TR. The study will look at how often serious problems related to the device occur, and how successful the procedure is, both during the procedure and up to 30 days afterward. The study is currently unclear on its recruitment status and plans to enroll 30 participants.
- Study design
- This is an early feasibility study, meaning it's an early look at the device. It's a single-arm, open-label study, which means all participants receive the Trisol System and everyone knows what treatment is being given. It plans to enroll 30 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures outcomes up to 30 days after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Trisol System EFS Study
At a glance
Conditions
NCT04905017
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Columbia University Medical Center/NYPH
New York, New Yorkstudy coordinator listed
Recruiting
Main Line Health / Lankenau Institute for Medical Research
Wynnewood, Pennsylvaniastudy coordinator listed
Not yet recruiting
Piedmont Heart Institute
Atlanta, Georgiastudy coordinator listed
Recruiting
University of Virginia Cardiology
Charlottesville, Virginiastudy coordinator listed
Recruiting
Vanderbilt University Medical Center
Nashville, Tennesseestudy coordinator listed
Recruiting
Cedars-Sinai Medical Center
Los Angeles, Californiano site contact published
Recruiting
Cleveland Clinic
Cleveland, Ohiono site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Isaac George, MD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Rate of device-related serious adverse eventsUp to 30 days
Rate of device-related serious adverse events, including death (cardiovascular and non- cardiovascular), MI (MVARC definitions), disabling stroke, life-threatening bleeding (MVARC type III-V), renal failure requiring dialysis, emergency surgery, need for additional surgical procedures due to device failure
- Rate of technical successDuring procedure
Technical success: delivery and deployment of the device in the correct position and retrieval of the delivery system.
- Rate of procedural successUp to 30 days
Procedural success: freedom from emergency surgery or reintervention related to the device or access procedure, without death, stroke, or device dysfunction
- Change in TR from baselineDuring procedure
Change in TR from baseline: reduction in TR grade immediately following implantation as compared to baseline TR grade, based on TEE imaging.