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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device
- ClinicalTrials.gov ID
- NCT06569602
- Acronym / sponsor ID
- 2024-07
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2033 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: Transcatheter Tricuspid Valve ReplacementTreatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Tricuspid Valve ReplacementAlso: Edwards EVOQUE Tricuspid Valve Replacement SystemReplacement of the tricuspid valve through a transcatheter approach | Device | Treatment |
Primary outcome
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)
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
6 secondary outcomes
All-cause mortality
Time frame: 30 days, 1 year, and 2 years
Cardiovascular mortality
Time frame: 30 days, 1 year, and 2 years
Heart failure hospitalizations
Time frame: 30 days, 1 year, and 2 years
Tricuspid valve re-intervention
Time frame: 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
NYHA Functional Class
Time frame: 30 days, 1 year, and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Related trials for Tricuspid Valve Regurgitation
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Not yet recruiting
TRI-SUCCESS - Tricuspid Regurgitation Study of the Unica™ Cross-Caval System for the Evaluation of Efficacy and Safety in Significant TR Subjects
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Recruiting
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Volker Rudolph, Prof. MD principal investigator
Herz-und Diabeteszentrum NRW, Bad Oeynhausen
Fabien Praz, Prof. MD principal investigator
Bern, Insespital, Switzerland
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Valve Regurgitation and Heart Valve Diseases, run by Edwards Lifesciences at 23 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, Spain, Greece, Italy, Switzerland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TMTT Clinical (+1-949-250-2500 or ext. +1800-424-3278, TMTT_Clinical@Edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tricuspid regurgitation grade (time frame: Up to 7 days, 30 days, and 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.