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

Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device

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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Regurgitation
• Intervention / Treatment: Device: Transcatheter Tricuspid Valve Replacement

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: TMTT Clinical; Phone Number: +1800-424-3278 +1-949-250-2500 or; Email: TMTT_Clinical@Edwards.com

Study Locations

• Germany
  • Bad Oeynhausen, Germany
    • Recruiting
    • Herz-und Diabeteszentrum NRW
    • Contact: Volker Rudolph, Prof. MD; Email: vrudolph@hdz-nrw.de
• Switzerland
  • Bern, Switzerland
    • Not yet recruiting
    • Inselspital
    • Contact: Fabien Praz, Prof. MD; Email: fabien.praz@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with at least severe tricuspid regurgitation who are candidates for transcatheter tricuspid valve replacement, selected to receive treatment with the EVOQUE system per the current Instructions for use, and meet the eligibility requirements.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment; Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System	Device: Transcatheter Tricuspid Valve Replacement; Replacement of the tricuspid valve through a transcatheter approach; Other Names: Edwards EVOQUE Tricuspid Valve Replacement System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days
Tricuspid regurgitation grade	Number of patients with optimal TR grade (≤1 on a 0-5 grade scale)	Up to 7 days, 30 days, and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Number of participants with all-cause mortality	30 days, 1 year, and 2 years
Cardiovascular mortality	Number of participants with cardiovascular mortality	30 days, 1 year, and 2 years
Heart failure hospitalizations	Number of patients with heart failure hospitalizations	30 days, 1 year, and 2 years
Tricuspid valve re-intervention	Number of participants with tricuspid valve re-intervention	30 days, 1 year, and 2 years
Health Status - Assessed by Kansas City Cardiomyopathy Questionaire (KCCQ) Scores	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).	30 days, 1 year, and 2 years
NYHA Functional Class	Number of patients with improvement in NYHA class	30 days, 1 year, and 2 years

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Volker Rudolph, Prof. MD, Herz-und Diabeteszentrum NRW, Bad Oeynhausen; Principal Investigator: Fabien Praz, Prof. MD, Bern, Insespital, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2033

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Tricuspid Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: 2024-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes