BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience. (NCT03495050) | Clinical Trial Compass
CompletedNot Applicable
BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
France150 participantsStarted 2018-06-05
Plain-language summary
Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.
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
. Age ≥18 years.
. NYHA≥2 and/or syncope and/or angina.
. Patient judged by the Heart Team as indicated for TAVI.
. Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.
. Estimated life-expectancy\>1 year.
Exclusion criteria
. Age \<18 years
. Asymptomatic patients
. Estimated life expectancy\<1 year
. Pure aortic regurgitation.
. LVEF\<20%
. No baseline MSCT evaluation.
. Unsuitable aortic root anatomy for Evolut Pro or XL.
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.
1Since this trial specifically studied transcatheter valve replacement using the Evolut platform in people with bicuspid aortic valve disease — a situation where TAVR has historically been considered more complex — can you tell me what the results showed about how well the valve performed in patients with this anatomy, and whether those results are relevant to my specific situation?
2This trial has already been completed, so would my doctor be able to share or discuss any published findings from BIVOLUTX that might help us compare the Evolut device's performance in bicuspid aortic valves versus other treatment options available to me today?
3Because bicuspid aortic valves have a different shape than the more common tricuspid valve, what specific risks or technical challenges did this trial's design account for, and how should those influence the conversation about whether a surgical or transcatheter approach makes more sense for me?
4The trial was labeled Phase NA, which often applies to device or registry studies rather than traditional drug trials — does that mean the safety and effectiveness profile of this valve for bicuspid anatomy is still being established, and how confident can we be in the data when weighing my options?
5Since valve performance was the main thing being measured in this study, what does 'valve performance' mean in practical terms for a patient — things like how well the valve opens, whether there's leakage, or how long it might last — and how do those metrics compare to what I might expect from open-heart surgery?
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.