NCT04100720

Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Biomedical Associates · Academic / Other
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral System for tricuspid valve replacement. Data collected in the clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years.

Detailed description

The Cardiovalve Transfemoral System for tricuspid valve replacement Data collected in the clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	Cardiovalve Transfemoral Tricuspid Valve	The Cardiovalve Transfemoral Tricuspid Valve System is intended for use in patients with severe, symptomatic Tricuspid regurgitation

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-12-01
• Completion: 2030-12-01
• First posted: 2019-09-24
• Last updated: 2024-08-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study