An interventional study of Transcatheter Tricuspid Valve Repair in Tricuspid Regurgitation, sponsored by Edwards Lifesciences. Active, not recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Edwards Lifesciences · Not applicable, Interventional, and Treatment
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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 2018, is one of 9 with no phase, and was the 4th 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 Germany, Greece, Italy and 3 more countries
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: 18 Years and older · 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 2018.
This study's planned enrollment of 75 is above the median of 60 across 129 interventional 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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Clinical Study of the Edwards Cardioband FIT Repair System
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards Cardioband FIT Repair System
Key Inclusion Criteria:
Key Exclusion Criteria:
Patients with conditions or anatomical considerations that preclude safe and successful procedure-related or study device access, deployment, or function, including but not limited to:
Primary tricuspid valve disease
Any physical impairment which limits the patient's capacity to complete functional testing due to other medical conditions independent of their TR (e.g., orthopedic condition)
Currently participating in another biologic, drug, or device study
Any of the following cardiovascular procedures:
Any of the following underlying medical conditions:
Pregnant, breastfeeding, or planning pregnancy within the next 12 months
Concurrent medical condition with a of less than 12 months in the judgment of the Investigator
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with the Edwards Cardioband FIT Repair System
Device: Transcatheter Tricuspid Valve Repair
Repair of the tricuspid valve through a transcatheter approach
Also known as: Edwards Cardioband Tricuspid Valve Repair
Primary Safety Endpoint -Composite Major Adverse Event (MAE) Rate
Number and percentage of patients who experienced at least one major adverse event (MAE).
Time frame: 30 days
Primary Performance Endpoint - Intraprocedural Success
Number of patients who had Intraprocedural Success, definition modified from TVARC criteria. Per patient analysis.
Time frame: Intraprocedural
Primary Performance Endpoint - Clinical Success
Number of patients who had Clinical Success at 30 days and 1 year, definition modified from TVARC criteria. Per patient analysis.
Time frame: 30 days and 1 year
Plan to share: No
Started Jul 2018 (actual). Primary completion is estimated for Dec 2026, 101 months after the start.
Of 55 industry-sponsored interventional studies with no phase under Tricuspid Valve Insufficiency, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 70. This study's planned 101 months is above that.
Counting every sponsor, half of 86 studies reached it within 38 months; a quarter within 23 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Tricuspid Valve Insufficiency →