Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
United States150 participantsStarted 2018-10-30
Plain-language summary
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
Who can participate
Age range
60 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
. Severe aortic stenosis, defined as follows:
. For symptomatic patients:
. For asymptomatic patients:
. Patient is considered low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR \<3% at 30 days per multidisciplinary local heart team assessment.
. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT.
. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Exclusion criteria
. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve).
. Age less than 60 years
. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:
. aspirin or heparin (HIT/HITTS) and bivalirudin
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 study is specifically for people with a bicuspid aortic valve, can you help me understand whether my particular valve anatomy and severity of disease would fit the kind of patients enrolled in this trial?
2This trial is looking at safety and device success at just 30 days after the procedure — what does that tell us about what's known so far for longer-term outcomes with TAVR in bicuspid aortic valve patients, and how does that compare to surgical valve replacement data?
3The study is no longer enrolling new patients but is still active — does that mean results or follow-up data might be available soon, and could that information change the recommendation for my treatment?
4Given that I have a bicuspid aortic valve, which is different from the more common tricuspid valve that most TAVR studies have focused on, how confident are you that TAVR is as safe and effective for my anatomy as it would be for someone with a tricuspid valve?
5Would it make more sense for me to consider standard open-heart surgery first, or wait for the full results of this Medtronic bicuspid TAVR study before deciding on a minimally invasive approach?
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
1
Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure.
Timeframe: 30 days
2
Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure.
. Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.