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New valve replacement could fix leaky hearts without cutting chest open

NCT ID NCT04433065

Disease control Sponsor: Medtronic Cardiovascular 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 5 times

Summary

This study tests a new device that replaces a leaky tricuspid heart valve using a thin tube inserted through a leg vein, avoiding open-heart surgery. It includes 150 people with severe tricuspid regurgitation who are too high-risk for surgery. The goal is to see if the device is safe and works well.

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 150 people

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

Started

Oct 2020

Expected to finish

Aug 2031

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: * Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement * Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team * Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE) * New York Heart Association (NYHA) Function Class II or greater * Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access * Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits * Subject meets the legal minimum age to provide informed consent based on local regulatory requirements Exclusion Criteria: * Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions * Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions) * Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus * Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system * Echocardiographic evidence of severe right ventricular dysfunction * Left ventricular ejection fraction (LVEF) \<30 as measured by resting echocardiogram within 30 days of the Index Procedure * Need for emergent or urgent surgery * Untreated clinically significant coronary artery disease requiring revascularization * Carcinoid tricuspid regurgitation

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Conditions

The condition(s) this trial relates to.

tricuspid valve insufficiency

As listed by the trial registrant

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

Tricuspid regurgitation

Contacts and locations

Locations

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Abrazo Arizona Heart Hospital

    Phoenix, Arizona, 85016, United States

  • Aurora Saint Lukes Medical Center

    Milwaukee, Wisconsin, 53125, United States

  • California Pacific Medical Center

    San Francisco, California, 94115, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Corewell Health

    Grand Rapids, Michigan, 49503, United States

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • New York-Presbyterian Hospital Columbia University Medical Center

    New York, New York, 10032, United States

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214, United States

  • Oregon Health & Science University Hospital

    Portland, Oregon, 97239, United States

  • Providence Saint Patrick Hospital

    Missoula, Montana, 59802, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45242, United States

  • The Mount Sinai Hospital

    New York, New York, 10029, United States

  • UPMC Pinnacle Harrisburg Campus

    Harrisburg, Pennsylvania, 17101, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham (UAB) Hospital

    Birmingham, Alabama, 35233, United States

  • University of Michigan Health System - University Hospital

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.