EFS of the DUO System for Tricuspid Regurgitation
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).
| Condition(s) | Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 participate | Inclusion Criteria: 1. Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab. 2. Patient is symptomatic despite medical therapy. 3. The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention. 4. The Patient's anatomy is suitable in the judgment of the Patient Selection Committee. 5. Age ≥18 years 6. The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent. Exclusion Criteria: 1. Patient is currently participating in another clinical investigation that could affect the outcome of this trial. 2. Any previous tricuspid valve intervention that would interfere with the placement of the investigational device. 3. Moderate or greater tricuspid valve s |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | CroiValve Limited |
| Locations | Phoenix, Arizona, United States; Thousand Oaks, California, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Wichita, Kansas, United States; Minneapolis, Minnesota, United States (+9 more sites) |
| Start date | 2024-08-13 |
| NCT ID | NCT05913908 |
| Official listing | https://clinicaltrials.gov/study/NCT05913908 |