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

Edwards Lifesciences

Status: Enrolling

Conditions: Heart Valve Diseases; Cardiovascular Diseases; Tricuspid Valve Regurgitation

Treatments: Device: Transcatheter Tricuspid Valve Replacement

Study type: Observational

Funder types: Industry

Identifiers

NCT06569602

2024-07

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement with the EVOQUE system per the current instructions for use.
2. Patient agrees to attend follow-up assessments.
3. Patients provided written informed consent for participation in the study.

Exclusion criteria

1. Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s).
2. Any patient considered to be part of a vulnerable population.

Trial design

500 participants in 1 patient group

Treatment

Description:

Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System

Treatment:

Device: Transcatheter Tricuspid Valve Replacement