The ShortCut™ Continued Access Study Protocol (NCT06211296) | Clinical Trial Compass
CompletedNot Applicable
The ShortCut™ Continued Access Study Protocol
United States8 participantsStarted 2024-07-03
Plain-language summary
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
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
. Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.
. Patient is at risk for TAVR-induced coronary artery ostium obstruction.
. Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations, prior to initiation of any study mandated procedure.
Exclusion criteria
. An excessive aortic valve leaflet Calcium morphology, such as diffuse massive calcification at the targeted leaflet for splitting or anatomy not suitable for the use of the ShortCut™ device, as determined by the CT measurements.
. Carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of carotid stenosis ≤ 1 month prior to index procedure.
. CVA or TIA ≤ 6 months prior to index procedure.
. History of a myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance.
. LVEF \< 30%.
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.
1This trial used a device called the ShortCut to split valve leaflets during a valve-in-valve procedure for aortic stenosis — can you explain what leaflet splitting is, why it matters for my situation, and whether this approach might be relevant to my care?
2The trial tracked serious outcomes like mortality and stroke related to the ShortCut device and procedure — what does that tell us about the known risks of this technique compared to a standard valve-in-valve procedure or other options for treating my aortic stenosis?
3Since this study is now completed, has the ShortCut device been reviewed or approved based on those results, and is it something that would actually be available to me at your center?
4The trial measured success using echocardiography and angiography — if this kind of procedure were considered for me, how would you monitor whether it worked, and what would happen if it didn't achieve the intended result?
5Given that this was a continued access study rather than a traditional Phase 1, 2, or 3 trial, what does that mean for how confident you are in the safety and effectiveness data, and should I be looking at any other treatment paths before considering a newer device-based 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.