An observational study in Tricuspid Valve Regurgitation, Heart Valve Diseases and Cardiovascular Diseases, sponsored by Edwards Lifesciences. Recruiting at 23 sites in 6 countries. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Edwards Lifesciences · Observational
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Among 14 studies in Tricuspid Valve Insufficiency by Edwards Lifesciences — 4 open to participants now, 10 under way, none of them phase 3. Tricuspid Valve Insufficiency · Edwards Lifesciences.
Among the 14 studies in Tricuspid Valve Insufficiency by Edwards Lifesciences, this one is the only one that started in 2024, is one of 5 observational ones, and was the 12th registered.
227 studies on the registry are indexed under Tricuspid Valve Insufficiency; 110 are open to participants now.
Browse Tricuspid Valve Insufficiency studies →4 of the 14 studies in Tricuspid Valve Insufficiency by Edwards Lifesciences are open now, in 8 countries. Recruiting first, the newest first:
Edwards Lifesciences · Sites in United States
Ages 65+
Edwards Lifesciences · Sites in United States, Canada
Ages 18+
Edwards Lifesciences · Sites in United States
Ages 65+
By country, each count listing its studies:
Of the 82 Tricuspid Valve Insufficiency studies recruiting now, 68 (83%) set no upper age limit and none (0%) stop at 75 or younger; 7 take children under 18; 2 take healthy volunteers.
This study: all sexes · no healthy volunteers.
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14 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 1 started in 2024.
This study's planned enrollment of 500 is above the median of 200 across 94 observational studies indexed under Tricuspid Valve Insufficiency.
Median enrollment 65 across the 9 interventional studies, 500 across the 5 observational. Of the 4 that completed or were terminated, 4 (100%) have results posted.
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Edwards Lifesciences is the lead sponsor of 128 studies on the registry; 18 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 33 (94%) have results posted.
1 of the studies in Tricuspid Valve Insufficiency by Edwards Lifesciences that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03382457Edwards LifesciencesClinical Study of Edwards Cardioband FIT Valve Repair System | 2026-12-31 |
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Among the 14 studies in Tricuspid Valve Insufficiency by Edwards Lifesciences, from their registry updates:
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This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
Device: Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Also known as: Edwards EVOQUE Tricuspid Valve Replacement System
Tricuspid regurgitation grade
Number of patients with optimal TR grade (≤1 on a 0-5 grade scale)
Time frame: 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
Time frame: 30 days
All-cause mortality
Number of participants with all-cause mortality
Time frame: 30 days, 1 year, and 2 years
Cardiovascular mortality
Number of participants with cardiovascular mortality
Time frame: 30 days, 1 year, and 2 years
Heart failure hospitalizations
Number of patients with heart failure hospitalizations
Time frame: 30 days, 1 year, and 2 years
Tricuspid valve re-intervention
Number of participants with tricuspid valve re-intervention
Time frame: 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).
Time frame: 30 days, 1 year, and 2 years
NYHA Functional Class
Number of patients with improvement in NYHA class
Time frame: 30 days, 1 year, and 2 years
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Started Oct 2024 (actual). Primary completion is estimated for Sep 2030, 71 months after the start.
Of 46 observational studies under Tricuspid Valve Insufficiency, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 106. This study's planned 71 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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