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Can a catheter valve replace Open-Heart surgery for a leaky heart valve?

NCT ID NCT06137807

Disease control Sponsor: P+F Products + Features USA Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests a device called the TricValve system in people with severe tricuspid regurgitation, a condition where the heart's tricuspid valve leaks blood backward. The device is implanted through a catheter into the veins leading to the heart, aiming to reduce symptoms without open-heart surgery. Researchers will measure how the device affects survival, heart failure episodes, walking ability, and quality of life. The study includes 50 adults with severe tricuspid regurgitation who have symptoms despite medical therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TricValve Transcatheter Bicaval Valve System, a device implanted through a catheter to replace the function of the tricuspid valve without open-heart surgery
What this could lead to
If it works, this could offer a less invasive treatment option for people with severe tricuspid regurgitation who are too sick for surgery, potentially improving symptoms and quality of life.
What could go wrong
This is a small, early-stage trial with only 50 participants, so results may not apply to everyone. The procedure carries risks like bleeding, stroke, or device-related complications, and the device may not improve outcomes for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject must be 18 years or older, at the time of signing the informed consent. 2. Subjects has severe tricuspid regurgitation (TR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab. 3. NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months. 4. Subject is adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team for at least 30 days prior to the index procedure, including a diuretic. 5. The local Heart Team and IEC determine that the patient is eligible for the TricValve procedure. 6. For females of childbearing potential, negative pregnancy test. 7. Capable of giving signed informed consent. Exclusion Criteria: 1. Subject had a recent MI, stroke or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention or other major cardiovascular surgery within 90 days prior to TricValve implantation. 2. Subject requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis, severe mitral regurgitation), coronary artery bypass or PCI or pulmonary valve correction. Please note that if closure of an ASD, iatrogenic ASD or PFO is performed, TricValve implantation can be performed 30 days after the intervention. Additionally, TricValve implantation can be performed 30 days after any Electrophysiology procedure (pacemaker, ICD, etc.). 3. LVEF ≤ 30% on echocardiography. 4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation. 5. Tricuspid stenosis. (Per TVARC, echo criteria: TVA at least 1.5 cm2 or TVAi at least 0.9 cm2/m2 \[at least 0.75 if BMI \>30 kg/m2\], DVI \<2.2, mean gradient \<5mm Hg); reduction of total tricuspid regurgitation to optimal (≤ mild \[1+\]) or acceptable (≤ moderate \[2+\]). 6. Severe right ventricular dysfunction. 7. Cardiac amyloidosis 8. Pulmonary artery systolic pressure (PASP) \>65 mmHg assessed with Echo Doppler and /or right heart catheterization. 9. Lower extremity venous thrombosis and/or the presence of an IVC filter at the time of or 6 months prior to TricValve procedure. 10. Hemodynamically significant pericardial effusion. 11. Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heart failure) 12. Any known allergy or hypersensitivity to nitinol, bovine tissue or contrast media that cannot be adequately treated with pre-medication. 13. Unable to tolerate anticoagulation/antiplatelet therapy 14. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure. 15. Any known life-threatening condition with an estimated life span of at least 12 months. 16. Platelet count \< 75,000/mm3 17. Child-Pugh Severity Class C (10-15 points). 18. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73 m2 or requiring chronic renal replacement therapy at the time of enrollment. 19. Endocarditis or active/ongoing infection requiring antibiotics. 20. Unable to walk at least 60 meters in a 6minute walk test. 21. Known bleeding or clotting disorders or patient refuses blood transfusion. 22. Active gastrointestinal (GI) bleeding within 3 months of randomization. 23. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV. 24. Use or participation in other investigational device or drug study in which patient has not reached a primary endpoint to treat cardiovascular conditions related to the outcomes of the current study. 25. Any other condition that would preclude ability to meet study requirements in the opinion of the investigator. 26. Psychiatric/behavioral issues or other medical or social conditions that preclude valid consent and follow-up 27. Pregnant or breastfeeding subjects and those who plan pregnancy during the clinical investigation follow-up period.

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Conditions

The condition(s) this trial relates to.

heart failure tricuspid valve disorder tricuspid valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tricuspid regurgitation Tricuspid valve disease

Contacts and locations

Locations

  • Ascension Medical Group St. Vincent The Heart Center of Indiana

    Indianapolis, Indiana, 46260, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360, United States

  • Carilion Clinic

    Roanoke, Virginia, 24014, United States

  • Chicago Advocate Christ

    Palos Park, Illinois, 60464, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44106, United States

  • Delray Medical Center

    Delray Beach, Florida, 33484, United States

  • Duke Cardiology Clinic

    Durham, North Carolina, 27710, United States

  • Endeavor Health, Glenbrook Hospital

    Glenview, Illinois, 60026, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Intermountain Heart Institute - Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805, United States

  • Largo Medical Center

    Largo, Florida, 33770, United States

  • MUSC

    Charleston, South Carolina, 29425, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • MedStar Washington Hospital Center

    Multiple Locations, Washington, 20010, United States

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Oregon Health Services

    Portland, Oregon, 97239, United States

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214, United States

  • Saint Luke's Mid America Heart Institute

    Kansas City, Missouri, 64111, United States

  • Scripps Memorial Hospital La Jolla

    San Diego, California, 92037, United States

  • Sentara Healthcare

    Norfolk, Virginia, 23507, United States

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • Tucson Medical Center

    Tucson, Arizona, 85712, United States

  • UCSF

    San Francisco, California, 94143, United States

  • UPMC Pinnacle

    Harrisburg, Pennsylvania, 17107, United States

  • UPMC Presbyterian Shadyside

    Pittsburgh, Pennsylvania, 15232, United States

  • UVA School of Medicine

    Charlottesville, Virginia, 22903, United States

  • University of Texas (Memorial Hermann)

    Houston, Texas, 77030, United States

  • Washington University St Louis

    St Louis, Missouri, 63110, United States

  • WellSpan York Hospital

    York, Pennsylvania, 17403, United States

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