Tricuspid Valve RegurgitationNCT06569602
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
An observational study of Tricuspid Valve Regurgitation and Heart Valve Diseases, run by Edwards Lifesciences at 23 sites in 6 countries.
Trial summary
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- What is being tested?
- Transcatheter Tricuspid Valve Replacement
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 23 sitesin 6 countries
- Study dates
- 1 Oct 2024to 30 Sep 2033
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
- Patient agrees to attend follow-up assessments.
- Patients provided written informed consent for participation in the study.
Who cannot join
- Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s).
- Any patient considered to be part of a vulnerable population.
Trial locations and contacts
23 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 6 countries
Germany17 sites, 16 recruiting
- Recruiting
Zentralklinik Bad Berka GmbH
Bad Berka
Bjoern Goebel, Dr.
- Recruiting
Kerckhoff-Klinik GmbH Bad Nauheim
Bad Nauheim
Tim Seidler, Prof. MD
- Recruiting
Rhoen-Klinikum Campus - Bad Neustadt
Bad Neustadt an der Saale
Sebastian Barth, Dr.
- Recruiting
Herz-und Diabeteszentrum NRW
Bad Oeynhausen
Volker Rudolph, Prof. MD, vrudolph@hdz-nrw.de
- Recruiting
Deutsches Herzzentrum der Charité (DHZC)
Berlin
Henryk Dreger, Dr.
- Recruiting
Herzzentrum Universitaet Bonn
Bonn
Georg Nickenig, Prof. MD
- Recruiting
St. Johannes Hospital Dortmund
Dortmund
Helge Moellmann, Prof. MD
- Recruiting
Universitatsklinik Essen
Essen
Tienush Rassaf, Prof. MD
- Recruiting
Asklepios Klinik St Georg Hamburg
Hamburg
Eike Tigges, Dr.
- Recruiting
Universitaetsklinikum Schleswig Holstein Campus Kiel
Kiel
Derk Frank, Prof. MD
- Recruiting
Leipzig Herzzentrum
Leipzig
Tobias Kister, Dr.
- Recruiting
Universitaetsklinikum Schleswig Holstein Campus Lubeck
Lübeck
Christian Frerker, Dr.
- Recruiting
Johannes Gutenberg Universitaet Mainz
Mainz
Stephan Von Bardeleben, Prof. MD
- Recruiting
Deutsches Herzzentrum Muenchen (DHM)
Munich
Hendrik Ruge, Dr.
- Recruiting
Klinikum der Universitaet Muenchen - Grosshadern
Munich
Joerg Hausleiter
Joerg Hausleiter, Prof. MD
- Recruiting
Universitaetsklinikum Tuebingen
Tübingen
Tobias Geisler, Prof. MD
- Active, not recruiting
Universitaetsklinikum Ulm
Ulm
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clinico San Carlos - Madrid
Madrid
Luis Nombela Franco, Dr.
- Recruiting
University Hospital Ramon Y Cajal Madrid
Madrid
Jose Zamorano, Prof. MD
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino Milano
Milan
Federico De Marco, Dr.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital
Bern
Fabien Praz, Prof. MD, fabien.praz@insel.ch
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford John Radcliffe Hospital
Oxford
Sam Dawkins, Dr.
About this study
Official title: 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.
Read the 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.
- Being tested
- Transcatheter Tricuspid Valve Replacement
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Valve Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Tricuspid Valve ReplacementDevice
Also called Edwards EVOQUE Tricuspid Valve Replacement System
Replacement of the tricuspid valve through a transcatheter approach
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System Receives: Device: Transcatheter Tricuspid Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tricuspid regurgitation grade
Number of patients with optimal TR grade (≤1 on a 0-5 grade scale)
Measured: Up to 7 days, 30 days, and 1 year
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
Measured: 30 days
Secondary outcomes (6)
All-cause mortality
Number of participants with all-cause mortality
Measured: 30 days, 1 year, and 2 years
Cardiovascular mortality
Number of participants with cardiovascular mortality
Measured: 30 days, 1 year, and 2 years
Heart failure hospitalizations
Number of patients with heart failure hospitalizations
Measured: 30 days, 1 year, and 2 years
Tricuspid valve re-intervention
Number of participants with tricuspid valve re-intervention
Measured: 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).
Measured: 30 days, 1 year, and 2 years
NYHA Functional Class
Number of patients with improvement in NYHA class
Measured: 30 days, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Oct 2024
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Volker Rudolph, Prof. MD, Principal investigator, Herz-und Diabeteszentrum NRW, Bad OeynhausenFabien Praz, Prof. MD, Principal investigator, Bern, Insespital, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569602
- Sponsor's protocol ID
- 2024-07
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes