NCT03700918

First in Human Study of the DaVingi™ TR System in the Treatment of Patients With Functional Tricuspid Regurgitation

A First in Human Study to Assess Safety and Performance of the DaVingi™ System in the Treatment of Patients With Functional Tricuspid Regurgitation

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

Summary

The DaVingi™ System is a percutaneous trans-catheter device delivered using right heart catheterization through the right internal jugular vein. The DaVingi™ System is designed for performing ring annuloplasty by using a Ring Delivery System to place a complete, flexible fabric ring around the annulus of the atrial side of the tricuspid valve. Fluoroscopy and echocardiography are used to monitor the ring placement procedure.

Detailed description

The annuloplasty ring is a small multi-element ring, consisting of an outer fabric layer, a pre-set stakes array and internal adjustment cord that can be adjusted at a later stage after the outer layer of the ring and stakes are encapsulated in new tissue growth. Once implanted, the ring is designed to serve as a foundation for promoting new annular tissue growth, effectively growing a new adjustable annulus around the valve. the study has been approved by Institutional Review Boards and Competent Authorities in Czech Republic, France and Israel.

Conditions

• Functional Tricuspid Regurgitation (TR)

Interventions

Type	Name	Description
DEVICE	DaVingiTR System	DaVingiTR Tricuspid valve annuloplasty repair device

Timeline

• Start date: 2017-11-11
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2018-10-09
• Last updated: 2021-11-12

Locations

5 sites across 3 countries: Czechia, France, Israel