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

Recruiting

• Conditions: Tricuspid Valve Regurgitation; Cardiovascular Diseases; Heart Valve Diseases
• Interventions: Device: Transcatheter Tricuspid Valve Replacement

• Registration Number: NCT06569602
• Lead Sponsor: Edwards Lifesciences

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-26
• Status Verified: 2024-10
• Study Start: 2024-10-01
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31
• Primary Completion: 2030-09-30
• Study Completion: 2033-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	Transcatheter Tricuspid Valve Replacement	Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System

Primary Outcome Measures

Name	Time	Method
Number of patients with major adverse events (MAE rates)	30 days	The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
Tricuspid regurgitation grade	Up to 7 days, 30 days, and 1 year	Number of patients with optimal TR grade (≤1 on a 0-5 grade scale)

Secondary Outcome Measures

Name	Time	Method
Health Status - Assessed by Kansas City Cardiomyopathy Questionaire (KCCQ) Scores	30 days, 1 year, and 2 years	KCCQ is a 23-item, self-administered, validated questionnaire that quantifies physical function, symptoms, social function, self-efficacy, and quality of life for patients with heart failure. Scores range from 0 to 100 with higher scores indicating better function (100 = no symptoms, no limitations, and excellent quality of life).
All-cause mortality	30 days, 1 year, and 2 years	Number of participants with all-cause mortality
Cardiovascular mortality	30 days, 1 year, and 2 years	Number of participants with cardiovascular mortality
Heart failure hospitalizations	30 days, 1 year, and 2 years	Number of patients with heart failure hospitalizations
Tricuspid valve re-intervention	30 days, 1 year, and 2 years	Number of participants with tricuspid valve re-intervention
NYHA Functional Class	30 days, 1 year, and 2 years	Number of patients with improvement in NYHA class

Trial Locations

Locations (2)

Herz-und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Inselspital; 🇨🇭 Bern, Switzerland