Cure My Disease

Don't miss your cure!

 Log in / Sign up

Suspended study tracks Valve-in-Valve outcomes for aortic valve patients

NCT ID NCT04902053

Knowledge-focused Sponsor: Edwards Lifesciences 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 05, 2026 · Updated 3 times

Summary

This study follows 50 people who previously received an INSPIRIS RESILIA aortic valve and now need a valve-in-valve procedure because their original valve is not working well. Researchers will track complications like death, stroke, bleeding, and valve movement, as well as how well the new valve expands. The goal is to gather safety and performance data, not to test a new treatment.

What this could mean

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

Active substance
Edwards transcatheter aortic valve (TAVR) used in valve-in-valve procedure
What this could lead to
If successful, this study could provide data to improve safety and effectiveness of valve-in-valve treatments for patients with failing INSPIRIS RESILIA aortic valves.
What could go wrong
This is a small, observational study (50 participants) that is currently suspended. It does not test a new treatment but gathers information, so no direct benefit to participants is guaranteed.

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.

Participants

About 50 people

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

Expected to start

Jun 2028

An estimate. Start dates often move.

Expected to finish

Jan 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.

Who is studied

Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment

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: Subjects must meet all of the following Inclusion Criteria: 1. 18 years or older at the time of the TAVR ViV treatment 2. Has an INSPIRIS RESILIA aortic valve implanted in the aortic position confirmed to be size 19mm, 21mm, 23mm or 25mm 3. A ViV procedure using an Edwards transcatheter aortic heart valve (TAVR) has been scheduled; or completed within 37 days from time of consent 4. The participant agrees to attend a follow-up assessment at 1 month post ViV procedure 5. The participant provides written informed consent prior to the post-ViV procedure CT scan Exclusion Criteria: Subjects must not meet any of the following Exclusion Criteria: 1. The INSPIRIS RESILIA aortic valve size is * Unconfirmed, or * Confirmed to be 27mm or 29mm 2. Prior re-interventions have been performed on the INSPIRIS RESILIA aortic valve 3. The INSPIRIS RESILIA aortic valve has been subjected to balloon aortic valvuloplasty (BAV) prior to the baseline quantitative area measurement of the valve area 4. The Subject is pregnant or desires to become pregnant within 40 days of the ViV procedure 5. Subjects with a known contraindication or hypersensitivity to contrast media that cannot be adequately pre-medicated per hospital guidelines

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Aortic valve disease are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

aortic valve disorder

As listed by the trial registrant

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

Aortic valve replacement

How to take part

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

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Nyph/Cumc

    New York, New York, 10032, United States

  • St. Vincent Hospital

    Indianapolis, Indiana, 46290, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • University of Florida

    Gainesville, Florida, 32611, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

More trials for these conditions

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