RecruitingNCT04905017
Trisol System EFS Study
AI Description
The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
- Who can join
- adult, older adult
- Participants
- 30
- Expected completion
- 2031-07-01
- Funded by
- industry
Conditions studied
Tricuspid Regurgitation
What is being tested
- DEVICE: Transcatheter Tricuspid Valve Replacement
What it measures
- Change in TR from baseline, Change in TR from baseline: reduction in TR grade immediately following implantation as compared to baseline TR grade, based on TEE imaging., During procedure
- Rate of device-related serious adverse events, 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, Up to 30 days
- Rate of procedural success, Procedural success: freedom from emergency surgery or reintervention related to the device or access procedure, without death, stroke, or device dysfunction, Up to 30 days
- Rate of technical success, Technical success: delivery and deployment of the device in the correct position and retrieval of the delivery system., During procedure
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2025-11-21
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.