TANDEM II
EFS of the DUO System for Tricuspid Regurgitation
AI Description
The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).
- Who can join
- adult, older adult
- Participants
- 15
- Expected completion
- 2029-10
- Funded by
- industry
Conditions studied
Heart Valve Diseases, Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency
What is being tested
- DEVICE: DUO Transcatheter Tricuspid Coaptation Valve System
What it measures
- Freedom from device or procedure related MAEs, * Death * Reintervention * Disabling stroke * Myocardial infarction * Major access site and vascular complications * Severe bleeding * Renal failure requiring dialysis * Major cardiac structural complications * Pulmonary embolism, At 30 days
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Abbott Northwestern Hospital
Minneapolis, MN
Ascension Via Christi (Wichita)
Wichita, KS
Dignity Health St. Joseph's Hospital and Medical Center
Phoenix, AZ
Los Robles Regional Medical Center
Thousand Oaks, CA
Methodist Hospital
San Antonio, TX
Northwestern Memorial Hospital
Chicago, IL
OhioHealth Riverside Methodist Hospital
Columbus, OH
Piedmont Atlanta Hospital
Atlanta, GA
University of Washington Medical Center
Seattle, WA
UPMC Harrisburg
Harrisburg, PA
Registry entry updated 2026-06-01
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.