NCT06033274

Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment: the TRIPLACE Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the timing and onset of conduction disturbances necessitating permanent pacemaker implantation, and how such patients are managed. On this background, the TRIPLACE Registry - an investigator-initiated global multicenter registry - is aimed at better understanding the safety and efficacy of orthotopic TTVR.

Detailed description

The primary aims of the registry will be: * To examine the safety, efficacy, and long-term outcomes of TTVR * To assess the incidence of procedural complications and their correlations with adverse clinical outcomes * To investigate the impact of different pre/post-procedural factors on peri-procedural complications and long-term outcomes after TTVR * To explore the characteristics of patients deemed eligible for TTVR.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	Transcatheter Tricuspid Valve Replacement	All patients undergoing Transcatheter Tricuspid Valve Replacement for native tricuspid valve disease

Timeline

• Start date: 2023-10-05
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2023-09-13
• Last updated: 2025-09-10

Locations

21 sites across 7 countries: United States, Canada, Denmark, France, Germany, Italy, Spain