Early Feasibility Study (EFS) of the Cardiac Implants Percutaneous Ring Annuloplasty System for the Treatment of Functional Tricuspid Regurgitation
Cardiac Implants LLC
Summary
An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following implantation in patients suffering from ≥ moderate functional tricuspid regurgitation (FTR).
Description
An early feasibility, multi-center, prospective, single-arm, non-randomized study to assess the safety and performance of the CI Percutaneous Ring Annuloplasty System in patients suffering from ≥ moderate functional tricuspid regurgitation (FTR). Additional outcomes include short and long-term changes in echocardiographic, functional, and quality of life parameters post-adjustment. The CI Ring Annuloplasty System is a percutaneous transcatheter repair device delivered by right heart catheterization through the right internal jugular vein. The System is designed to perform annuloplasty using a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines. 2. Tricuspid valve annular diameter ≥ 40mm or \> 21 mm/m2 as measured by baseline TTE in a 4-chamber view within 90 days prior to index implant procedure. 3. Age ≥ 18 years old at the time of enrollment. 4. New York Heart Associate Classification ≥ II. 5. Symptoms of right heart failure despite optimized medical therapy. 6. Multidisciplinary heart team (minimum of four physicians, including imaging, Structural Heart Disease In…
Interventions
- DeviceCI Percutaneous Ring Annuloplasty System
Percutaneous transcatheter implant and adjustment of the CI ring annuloplasty system.
Locations (2)
- Hackensack University Medical CenterHackensack, New Jersey
- Weill Cornell Medicine-New York Presbyterian HospitalNew York, New York