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

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

Sex: All

Healthy volunteers: No

Enrollment: 500

Sponsor: Edwards Lifesciences

Location: Zentralklinik Bad Berka GmbH Bad Berka

Summary

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

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06569602). StuddyBuddy aggregates publicly available trial information.