Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation
CroiValve Limited
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).
Description
Multi-center, prospective, non-randomized, investigational, and pre-market. Data collected in this clinical study will include safety and function of the investigational system as well as up to 5 year clinical outcomes.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 investigatio…
Interventions
- DeviceDUO Transcatheter Tricuspid Coaptation Valve System
Reduction of tricuspid regurgitation through a transcatheter approach
Locations (16)
- Dignity Health St. Joseph's Hospital & Medical CenterPhoenix, Arizona
- Los Robles Hospital & Medical CenterThousand Oaks, California
- Piedmont Heart InstituteAtlanta, Georgia
- Northwestern UniversityChicago, Illinois
- Ascension Via Christi ResearchWichita, Kansas
- Allina Health Minneapolis Heart Institute FoundationMinneapolis, Minnesota