VISTA-US
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)
AI Description
The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).
- Who can join
- adult, older adult
- Participants
- 30
- Expected completion
- 2031-11-30
- Funded by
- industry
Conditions studied
Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders
What is being tested
- DEVICE: VDyne Transcatheter Tricuspid Valve Replacement System
What it measures
- Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs, Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs, Baseline to 1 month after implant
- Changes in functional capacity (6-minute walk test), Changes in functional capacity (6-minute walk test), Baseline to 1 month after implant
- Changes in in quality of life (KCCQ score), Changes in in quality of life (KCCQ score). A higher score indicates worsening quality of life outcomes, Baseline to 1 month after implant
- Changes in symptom status (NYHA class), Changes in symptom status (NYHA class), Baseline to 1 month after implant
- The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC)., The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC)., Implant to 30 days post-procedure
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Abbott Northwestern Hospital
Minneapolis, MN
Ascension Saint Thomas Hospital
Nashville, TN
Cedars-Sinai Medical Center
Los Angeles, CA
Henry Ford Health (Detroit)
Detroit, MI
Mayo Clinic (Rochester, Minnesota)
Rochester, MN
Montefiore Einstein Hospital (Moses Campus)
Bronx, NY
MUSC Health
Charleston, SC
OHSU Hospital
Portland, OR
The Christ Hospital
Cincinnati, OH
Registry entry updated 2026-03-31
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.