Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment (TRIPLACE)

Montefiore Medicine Academic Health System

Status: Enrolling

Conditions: Tricuspid Regurgitation

Treatments: Device: Transcatheter Tricuspid Valve Replacement

Study type: Observational

Funder types: Other

Identifiers

NCT06033274

2023-15312

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing Transcatheter Tricuspid Valve Replacement
• Native Tricuspid Valve disease
• Orthotopic Tricuspid Valve Implantation

Exclusion criteria

• Age under 18 years

Trial design

800 participants in 1 patient group

Patients with Tricuspid Regurgitation undergoing Transcatheter Tricuspid Valve Replacement

Description:

Patients having clinically significant tricuspid regurgitation, defined according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease, requiring transcatheter tricuspid valve replacement

Treatment:

Device: Transcatheter Tricuspid Valve Replacement