NCT06569602

Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)

Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.

Detailed description

This is a prospective, single-arm, multi-center, real-world study of an approved device. Up to 500 patients will be enrolled in this study at up to 45 sites in Europe. All enrolled patients will be assessed at the following intervals: baseline, index procedure, discharge (or 7-days post-index procedure whichever occurs first), 30 days, 1 year, and annually through 5 years. Study enrollment is expected to last approximately 2-4 years, followed by 5 years of follow-up.

Conditions

• Tricuspid Valve Regurgitation
• Heart Valve Diseases
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Transcatheter Tricuspid Valve Replacement	Replacement of the tricuspid valve through a transcatheter approach

Timeline

• Start date: 2024-10-01
• Primary completion: 2030-09-30
• Completion: 2033-09-30
• First posted: 2024-08-26
• Last updated: 2024-10-31

Locations

2 sites across 2 countries: Germany, Switzerland

Regulatory

• FDA-regulated device study