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

September 3, 2026 updated by: Edwards Lifesciences

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bad Berka, Germany
        • Recruiting
        • Zentralklinik Bad Berka GmbH
        • Contact:
          • Bjoern Goebel, Dr.
      • Bad Nauheim, Germany
        • Recruiting
        • Kerckhoff-Klinik GmbH Bad Nauheim
        • Contact:
          • Tim Seidler, Prof. MD
      • Bad Neustadt an der Saale, Germany
        • Recruiting
        • Rhoen-Klinikum Campus - Bad Neustadt
        • Contact:
          • Sebastian Barth, Dr.
      • Bad Oeynhausen, Germany
        • Recruiting
        • Herz-und Diabeteszentrum NRW
        • Contact:
      • Berlin, Germany
        • Recruiting
        • Deutsches Herzzentrum der Charité (DHZC)
        • Contact:
          • Henryk Dreger, Dr.
      • Bonn, Germany
        • Recruiting
        • Herzzentrum Universitaet Bonn
        • Contact:
          • Georg Nickenig, Prof. MD
      • Dortmund, Germany
        • Recruiting
        • St. Johannes Hospital Dortmund
        • Contact:
          • Helge Moellmann, Prof. MD
      • Essen, Germany
        • Recruiting
        • Universitatsklinik Essen
        • Contact:
          • Tienush Rassaf, Prof. MD
      • Hamburg, Germany
        • Recruiting
        • Asklepios Klinik St Georg Hamburg
        • Contact:
          • Eike Tigges, Dr.
      • Kiel, Germany
        • Recruiting
        • Universitaetsklinikum Schleswig Holstein Campus Kiel
        • Contact:
          • Derk Frank, Prof. MD
      • Leipzig, Germany
        • Recruiting
        • Leipzig Herzzentrum
        • Contact:
          • Tobias Kister, Dr.
      • Lübeck, Germany
        • Recruiting
        • Universitaetsklinikum Schleswig Holstein Campus Lubeck
        • Contact:
          • Christian Frerker, Dr.
      • Mainz, Germany
        • Recruiting
        • Johannes Gutenberg Universitaet Mainz
        • Contact:
          • Stephan Von Bardeleben, Prof. MD
      • Munich, Germany
        • Recruiting
        • Deutsches Herzzentrum Muenchen (DHM)
        • Contact:
          • Hendrik Ruge, Dr.
      • Munich, Germany
        • Recruiting
        • Klinikum der Universitaet Muenchen - Grosshadern
        • Contact:
          • Joerg Hausleiter
        • Principal Investigator:
          • Joerg Hausleiter, Prof. MD
      • Tübingen, Germany
        • Recruiting
        • Universitaetsklinikum Tuebingen
        • Contact:
          • Tobias Geisler, Prof. MD
      • Ulm, Germany
        • Active, not recruiting
        • Universitaetsklinikum Ulm
  • Greece
      • Athens, Greece
        • Active, not recruiting
        • Hygeia Hospital - Athens
  • Italy
      • Milan, Italy
        • Recruiting
        • Centro Cardiologico Monzino Milano
        • Contact:
          • Federico De Marco, Dr.
  • Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Clinico San Carlos - Madrid
        • Contact:
          • Luis Nombela Franco, Dr.
      • Madrid, Spain
        • Recruiting
        • University Hospital Ramon Y Cajal Madrid
        • Contact:
          • Jose Zamorano, Prof. MD
  • Switzerland
      • Bern, Switzerland
  • United Kingdom
      • Oxford, United Kingdom
        • Recruiting
        • Oxford John Radcliffe Hospital
        • Contact:
          • Sam Dawkins, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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)
Time Frame: 30 days
The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
30 days
Tricuspid regurgitation grade
Time Frame: Up to 7 days, 30 days, and 1 year
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
Time Frame: 30 days, 1 year, and 2 years
Number of participants with all-cause mortality
30 days, 1 year, and 2 years
Cardiovascular mortality
Time Frame: 30 days, 1 year, and 2 years
Number of participants with cardiovascular mortality
30 days, 1 year, and 2 years
Heart failure hospitalizations
Time Frame: 30 days, 1 year, and 2 years
Number of patients with heart failure hospitalizations
30 days, 1 year, and 2 years
Tricuspid valve re-intervention
Time Frame: 30 days, 1 year, and 2 years
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
Time Frame: 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).
30 days, 1 year, and 2 years
NYHA Functional Class
Time Frame: 30 days, 1 year, and 2 years
Number of patients with improvement in NYHA class
30 days, 1 year, and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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