NCT04890821

Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

Early Feasibility Study (EFS) of the Cardiac Implants Percutaneous Ring Annuloplasty System for the Treatment of Functional Tricuspid Regurgitation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Cardiac Implants LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 Ring Delivery System (RDS) to place a complete, flexible ring over the tricuspid annulus on the atrial side of the valve. Fluoroscopy and transesophageal echocardiography are used to guide and monitor the ring placement procedure. After implantation, the ring becomes embedded within the fibrous tissue of the tricuspid annulus. Approximately 3 months following implantation, the ring is manually adjusted under echocardiographic and fluoroscopic imaging using an Adjustment Tool (AT) until desired reduction of the tricuspid annulus dimension is achieved. Following adjustment, the AT releases a fastener, securing the ring once optimal annular reduction is achieved.

Conditions

• Tricuspid Regurgitation Functional

Interventions

Type	Name	Description
DEVICE	CI Percutaneous Ring Annuloplasty System	Percutaneous transcatheter implant and adjustment of the CI ring annuloplasty system.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-08-01
• Completion: 2027-09-01
• First posted: 2021-05-18
• Last updated: 2021-11-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study