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

Not yet recruiting

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

• Registration Number: NCT06569602
• Lead Sponsor: Edwards Lifesciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-12
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. The Local Site Heart Team determines that the patient is appropriate for<br> transcatheter tricuspid valve replacement with the EVOQUE system per the current<br> instructions for use.<br><br> 2. Patient agrees to attend follow-up assessments.<br><br> 3. Patients provided written informed consent for participation in the study.<br><br>Exclusion Criteria:<br><br> 1. Patient participating in another interventional biologic, drug, or device clinical<br> study that has not met its primary endpoint(s).<br><br> 2. Any patient considered to be part of a vulnerable population.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tricuspid regurgitation grade;Number of patients with major adverse events (MAE rates)

Secondary Outcome Measures

Name	Time	Method
All-cause mortality;Cardiovascular mortality;Heart failure hospitalizations;Tricuspid valve re-intervention;Health Status - Assessed by Kansas City Cardiomyopathy Questionaire (KCCQ) Scores;NYHA Functional Class