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

Edwards Lifesciences500 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Tricuspid Valve Regurgitation Heart Valve Diseases Cardiovascular Diseases

Interventions

Transcatheter Tricuspid Valve ReplacementDEVICE

Replacement of the tricuspid valve through a transcatheter approach

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (2)

Herz-und Diabeteszentrum NRW

Bad Oeynhausen, Germany

RECRUITING

Inselspital

Bern, Switzerland

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Tricuspid regurgitation grade

Number of patients with optimal TR grade (≤1 on a 0-5 grade scale)

Time frame: Up to 7 days, 30 days, and 1 year

Number of patients with major adverse events (MAE rates)

The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days

Time frame: 30 days