The ShortCut Post-Market Study
ConditionAortic Stenosis Treated With TAVI
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorPi-cardia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Any contraindication as specified in the approved device label.
An excessive aortic valve leaflet calcium morphology, as determined by CT assessment.
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.
Trial population
Patients ≥22 years old that plan to undergo a ViV TAVR procedure at risk for coronary obstruction.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR
DeviceA transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR, to reduce the risk of coronary obstruction and coronary access compromise and enable a valve-in-valve procedure.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Primary Safety Assessment
Each of the following ShortCut- and/or ShortCut procedure-related adverse events at initial cardiac hospitalization discharge or 7 days post-procedure, whichever occurs first, as assessed by the Clinical Events Committee (CEC): * Cardiovascular Mortality * All Stroke
Time frame
At discharge or 7 days post-procedure, whichever occurs first2
Primary Effectiveness Assessment
Rate of coronary patency of the coronary ostium adjacent to the treated leaflet by contrast aortography after TAVR implantation as assessed by a core lab.
Time frame
Immediately after TAVR procedureLocations
Source ClinicalTrials.gov
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