CompletedNot Applicable

The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis

Canada, United Kingdom100 participantsStarted 2018-06-01

Plain-language summary

This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.

Who can participate

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

. Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram criteria:
. New York Heart Association functional class ≥ II
. Judged by the Heart Team to be at intermediate risk for open surgical therapy
. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion criteria

. Native aortic annulus size unsuitable for available THV sizes on 3D imaging analysis
. Aortic valve is unicuspid, bicuspid or non-calcified
. Pre-existing mechanical or bioprosthetic valve in any position.
. Severe aortic regurgitation (\> 3+)
. Severe mitral regurgitation (\> 3+) or ≥ moderate stenosis
. Ventricular dysfunction with left ventricular ejection fraction \< 30%
. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation

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

Procedural Success

Timeframe: Day 0

Trial details

NCT IDNCT03471065

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-23

Results submitted2020-12-22

View on ClinicalTrials.gov More Aortic Valve Stenosis trials

Who can participate

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

. Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram criteria:
. New York Heart Association functional class ≥ II
. Judged by the Heart Team to be at intermediate risk for open surgical therapy
. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion criteria

. Native aortic annulus size unsuitable for available THV sizes on 3D imaging analysis
. Aortic valve is unicuspid, bicuspid or non-calcified
. Pre-existing mechanical or bioprosthetic valve in any position.
. Severe aortic regurgitation (\> 3+)
. Severe mitral regurgitation (\> 3+) or ≥ moderate stenosis
. Ventricular dysfunction with left ventricular ejection fraction \< 30%
. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation