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The ShortCut Post-Market Study
Sponsor: Pi-cardia
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.
Official title: A Prospective, Multicenter, Non-Randomized, Single-Arm, Post-Market Study of the ShortCut™ (The ShortCut PMS)
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2026-06
Completion Date
2027-09
Last Updated
2026-06-08
Healthy Volunteers
Not specified
Conditions
Interventions
Transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR
A 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.