Cure My Disease

Don't miss your cure!

 Log in / Sign up

New device plugs dangerous heart valve leaks without open surgery

NCT ID NCT04489823

Disease control Sponsor: Abbott Medical Devices 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a special plug device to close leaks that can form around surgically implanted heart valves. These leaks can cause serious problems like heart failure or anemia. The procedure is done through a catheter, avoiding the need for another open-heart surgery. The study includes 200 adults with moderate or worse leaks and aims to see if the device is safe and effective.

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 200 people

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

Started

Dec 2020

Expected to finish

Dec 2026

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: * Subject is implanted with a mechanical or biological surgical valve in the aortic or mitral position * Note: Subjects in European countries can only be implanted with a mechanical valve in the aortic or mitral position * Subject has a clinically significant paravalvular leak with a severity grade of moderate or higher, associated with signs of heart failure and/or hemolysis necessitating recurring blood transfusions. * Subject has one clinically significant PVL defect that can be closed with a single AVP III as assessed pre-procedurally * Subject has provided written informed consent * Subject is ≥18 years old Exclusion Criteria: * Subject has a rocking valve or extreme dehiscence of the prosthetic valve involving more than 40% of the sewing ring * Subject's PVL(s) originates from a transcatheter aortic or mitral valve replacement, or from rapid deployment or sutureless surgical replacement valves * Subject has a prosthetic aortic valve and prosthetic mitral valve which both have a clinically significant paravalvular leak. * Subject who is hemodynamically unstable or who cannot undergo an elective procedure * Subject with active endocarditis or other active infection * Subject has within the last 6 months a previously documented intracardiac mass, vegetation, tumor, or thrombus which would interfere with placement of the AVP III * Subject has inadequate vasculature for delivery of the AVP III * Subject has unsuitable anatomy for PVL closure using the AVP III (such as a PVL associated with an abscess cavity or a pseudoaneurysmal sac) or anatomy where the AVP III would interfere with other intracardiac or intravascular structures (such coronary ostia) * Subjects who are unable to receive intraprocedural anticoagulant therapy * Pregnant or nursing subjects or subjects who plan pregnancy during the clinical investigation follow-up period. * Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. * Life expectancy is less than 1 year in the opinion of the Investigator * Incapacitated individuals, defined as persons with mental illnesses or handicaps that impair their ability to provide informed consent, or individuals without legal authority to provide informed consent. * Individual who are currently participating in an investigational drug or device study that has not reached the primary endpoint or that may confound the results of this study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Paravalvular aortic regurgitation are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

aortic valve insufficiency

As listed by the trial registrant

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

Paravalvular aortic regurgitation

Contacts and locations

Locations

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120, United States

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014, United States

  • Edinburgh Heart Centre

    Edinburgh, Lothian, EH16 4SA, United Kingdom

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca

    Katowice, Silesian Voivodeship, 40-635, Poland

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hospital Ramón y Cajal

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario de Salamanca

    Salamanca, Spain

  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

    Montreal, Quebec, H1T 1C8, Canada

  • Institut de Cardiologie de Quebec (Hôpital Laval)

    Québec, Quebec, G1V 4G5, Canada

  • Intermountain Medical Center

    Murray, Utah, 84157, United States

  • Lenox Hill Hospital

    New York, New York, 10021, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407, United States

  • New York Presbyterian Hospital/Cornell University

    New York, New York, 10021, United States

  • Ospedale San Raffaele

    Milan, Lombard, 20132, Italy

  • Papworth Hospital NHS Foundation Trust

    Cambridge, United Kingdom

  • Providence Sacred Heart Medical Center

    Spokane, Washington, 99202, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • St. Antonius Ziekenhuis

    Nieuwegein, Utrecht, 3435 CM, Netherlands

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The Royal Sussex County Hospital

    Brighton, Soeast, BN25BE, United Kingdom

  • University Hospital - Univ. of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35249, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States