The ShortCut Post-Market Study (NCT07631988) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The ShortCut Post-Market Study
150 participantsStarted 2026-06
Plain-language summary
This is a post-market, prospective, multicenter, single-arm post market study sponsored by Pi-Cardia Ltd. The ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for subjects at risk for coronary obstruction. The ShortCut has been cleared by FDA under DEN240017, and this study is a post-market evaluation of the ShortCut per the FDA cleared indications for use.
The objectives of the study are:
1. To collect real-world data on the use of ShortCut to split bioprosthetic aortic valve leaflets prior to TAVR in subjects at risk for coronary obstruction.
2. To collect real-world data on coronary patency following ShortCut and ViV TAVR procedures in subjects who are at risk for coronary artery ostium obstruction.
Data will be collected, where available, from the subjects' medical records at the following time-points: baseline, index procedure, pre-discharge, and 30 days post-procedure.
Who can participate
Age range
22 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
. Male or female ≥ 22 years of age.
. Subject is planned to undergo a ViV TAVR procedure with the ShortCut, according to its labeling.
. Preprocedural evidence for risk for coronary occlusion during ViV TAVR in bioprosthetic valve failure.
. Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations
Exclusion criteria
. Any contraindication as specified in the approved device label.
. An excessive aortic valve leaflet calcium morphology, as determined by CT assessment.
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
1
Primary Safety Assessment
Timeframe: At discharge or 7 days post-procedure, whichever occurs first
. Anatomy that is not suitable for the use of the ShortCut, as determined by CT assessment.
. Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of such disease ≤ 1 month prior to index procedure.
. Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) ≤ 6 months prior to index procedure or severe neurological disability, as determined by the investigator.
. Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.