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New heart valve device aims to fix leaky tricuspid without open surgery

NCT ID NCT05913908

Disease control Sponsor: CroiValve Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study is testing a new device called the DUO System, which is placed through a catheter to reduce leakage in the tricuspid valve. The study will include 15 people with severe tricuspid regurgitation who still have symptoms despite medical therapy. The main goal is to see if the device is safe and works properly.

What this could mean

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

Active substance
DUO Transcatheter Tricuspid Coaptation Valve System (a device implanted via catheter to reduce tricuspid valve leakage)
What this could lead to
If successful, this could offer a less invasive treatment option for people with severe tricuspid regurgitation who are not candidates for open-heart surgery.
What could go wrong
This is a very early feasibility study with only 15 participants, so results may not apply to everyone. The device could cause serious complications like bleeding, stroke, or heart damage.

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 15 people

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

Started

Aug 2024

Expected to finish

Oct 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. Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab. 2. Patient is symptomatic despite medical therapy. 3. The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention. 4. The Patient's anatomy is suitable in the judgment of the Patient Selection Committee. 5. Age ≥18 years 6. The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent. Exclusion Criteria: 1. Patient is currently participating in another clinical investigation that could affect the outcome of this trial. 2. Any previous tricuspid valve intervention that would interfere with the placement of the investigational device. 3. Moderate or greater tricuspid valve stenosis. 4. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation 5. Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device. 6. Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair). 7. Ejection Fraction (EF) \<25% 8. Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation 9. Patient has Systolic Pulmonary Pressure (sPAP) \>60 mm Hg 10. Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices 11. Severe respiratory instability with continuous use of home oxygen 12. Severe right ventricular dysfunction 13. Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or interventional PCI. 14. Stroke or transient ischemic event within 90 days prior to the index procedure 15. Acute myocardial infarction within 30 days before the index procedure 16. Renal insufficiency (eGFR \<25 ml/min) or currently on chronic dialysis 17. Active endocarditis within 6 months of the index procedure 18. Pulmonary embolism or deep vein thrombosis within the last 6 months 19. Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure 20. Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis 21. Life expectancy \<1 year 22. Active infections requiring current antibiotic therapy 23. Known severe liver disease 24. Is on the waiting list for a transplant or has had a prior heart or lung transplant 25. Known active peptic ulcer or active GI bleed 26. Unable to take anticoagulant therapy 27. Any known major coagulation abnormalities, thrombocytopenia, platelets \< 50,000/ml or severe anemia Hb \<8 g/dl 28. Known patient is actively abusing drugs 29. Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) and/or the device materials, including nickel and titanium 30. Patients who are pregnant or intend to become pregnant 31. Any condition making it unlikely the Patient will be able to complete all protocol procedures (including compliance with optimal medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result

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Conditions

The condition(s) this trial relates to.

heart valve disorder tricuspid valve disorder tricuspid valve insufficiency

As listed by the trial registrant

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

Heart valve diseases Tricuspid regurgitation Tricuspid valve disease Tricuspid valve insufficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allina Health Minneapolis Heart Institute Foundation

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Ascension Via Christi Research

    RECRUITING

    Wichita, Kansas, 67214, United States

  • Columbia University Medical Center/NYPH

    RECRUITING

    New York, New York, 10032, United States

  • Dignity Health St. Joseph's Hospital & Medical Center

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • Intermountain Health

    RECRUITING

    Salt Lake City, Utah, 84111, United States

  • Los Robles Hospital & Medical Center

    RECRUITING

    Thousand Oaks, California, 91360, United States

  • Medical University of Silesia

    RECRUITING

    Katowice, 40-635, Poland

  • Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem Badawczym

    RECRUITING

    Warsaw, Warsaw, 04-628, Poland

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • OhioHealth Research Institute

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • San Antonio Methodist

    ENROLLING_BY_INVITATION

    San Antonio, Texas, 78229, United States

  • UPMC Pinnacle Harrisburg

    RECRUITING

    Harrisburg, Pennsylvania, 17050, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • Uniwersytetem Medycznym im. Karola Marcinkowskiego w Poznaniu

    RECRUITING

    Poznan, Poznan, 60-355, Poland

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