An interventional study of Edwards PASCAL System and Optimal Medical Therapy in Tricuspid Regurgitation, Tricuspid Valve Insufficiency and Tricuspid Valve Disease, sponsored by Edwards Lifesciences. Recruiting at 79 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
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 one of 3 that started in 2019, is one of 9 with no phase, and was the 7th 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
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. 3 started in 2019.
This study's planned enrollment of 1,270 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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To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team
A Prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation. Patients will be seen for follow-up visits at discharge, 30 days, 3 months, 6 months, and annually through 5 years.
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:
Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:
Any of the following cardiovascular procedures:
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
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.
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Device: Edwards PASCAL System
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Drug: Optimal Medical Therapy
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
Device: Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Device: Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
Also known as: Transcatheter tricuspid valve repair (TTVr)
Optimal Medical Therapy alone in patients with tricuspid regurgitation
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score)
Comparison of number of participants with composite endpoint events between experimental and active comparator arms
Time frame: 6 months
1 Grade Reduction in TR Severity
Total number of participants with at least 1 grade reduction in TR severity
Time frame: 6, 12 months
Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change in KCCQ score from baseline
Time frame: 3, 6, and 12 months
All Cause Mortality
Total number of deaths from any cause
Time frame: 12 months, 24 months
Death and Heart Failure Hospitalizations
Total number of deaths and hospital admissions due to heart failure
Time frame: 12 months
All-cause Mortality, TV Surgery or TV Interventions
Total number of deaths, TV surgeries or interventions
Time frame: 24 months
Right ventricular end-diastolic diameter (RVEDD mid)
Change in right ventricular end-diastolic diameter (RVEDD mid)
Time frame: 12 months
Major Adverse Events (MAEs)
Overall rate of Major Adverse Events (MAEs)
Time frame: 30 days
Reduction in TR grade
Reduction in TR severity as assessed by TEE pre- and post-implantation
Time frame: Intraprocedural post-implantation
All-Cause Mortality
Total number of deaths from any cause
Time frame: 12 months, annually through 5 years
Heart failure hospitalizations
Total number of hospital admissions due to heart failure
Time frame: 12 months, annually through 5 years
Non-elective tricuspid valve re-intervenitions (percutaneous or surgical)
Total number of non-elective tricuspid valve re-interventions
Time frame: 12 months, annually through 5 years
Durable RVAD implantation or heart transplant
Total number of patients requiring RVAD impantantion or heart transplant
Time frame: 12 months, annually through 5 years
Need for paracentesis
Total nunber of patients who required paracentesis
Time frame: 12 months, annually through 5 years
All cause mortality or the first heart failure hospitalization for patients with massive or torrential TR at baseline
Time to death or first heart failure hospitalization
Time frame: 12, 24 months
All-cause Hospitalizations
Number of hospitalizations for any cause
Time frame: 12 months
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Plan to share: No
No publications or documents are linked to this record.
Started Dec 2019 (actual). Primary completion is estimated for Dec 2027, 96 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 96 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.
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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Tricuspid Valve Insufficiency →