SuspendedNot Applicable

INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study

Stopped: Lack of enrollment. Study will be restarted when there is sufficient INSPIRIS Valve in Valve case volume to support enrollment.

United States50 participantsStarted 2028-06

Plain-language summary

The primary objective of the INSPIRIS RESILIA Aortic Valve-in-valve (ViV) Surveillance Study ("the Study") is to capture Adverse Event information and valve measurement data from dysfunctional INSPIRIS RESILIA aortic valves before and after Valve-in-valve (ViV) treatment.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18 years or older at the time of the TAVR ViV treatment
. Has an INSPIRIS RESILIA aortic valve implanted in the aortic position confirmed to be size 19mm, 21mm, 23mm or 25mm
. A ViV procedure using an Edwards transcatheter aortic heart valve (TAVR) has been scheduled; or completed within 37 days from time of consent
. The participant agrees to attend a follow-up assessment at 1 month post ViV procedure
. The participant provides written informed consent prior to the post-ViV procedure CT scan

Exclusion criteria

. The INSPIRIS RESILIA aortic valve size is

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Subject's Occurrence Rate of the Composite Safety Endpoint

Timeframe: Events occurring within 30 days of valve-in-valve procedure

Subject's Occurrence Rate of Valve Malpositioning

Timeframe: Events occurring within 30 days of valve-in-valve procedure

Subject's INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure Compared to Baseline

Timeframe: Day 30, compared to baseline

Trial details

NCT IDNCT04902053

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-12

View on ClinicalTrials.gov More Aortic Valve Replacement trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18 years or older at the time of the TAVR ViV treatment
. Has an INSPIRIS RESILIA aortic valve implanted in the aortic position confirmed to be size 19mm, 21mm, 23mm or 25mm
. A ViV procedure using an Edwards transcatheter aortic heart valve (TAVR) has been scheduled; or completed within 37 days from time of consent
. The participant agrees to attend a follow-up assessment at 1 month post ViV procedure
. The participant provides written informed consent prior to the post-ViV procedure CT scan

Exclusion criteria

. The INSPIRIS RESILIA aortic valve size is

What they're measuring

Subject's Occurrence Rate of the Composite Safety Endpoint

Timeframe: Events occurring within 30 days of valve-in-valve procedure

Subject's Occurrence Rate of Valve Malpositioning

Timeframe: Events occurring within 30 days of valve-in-valve procedure

Subject's INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure Compared to Baseline

Timeframe: Day 30, compared to baseline