Clinical Trial

The ShortCut Post-Market Study

Study acronym: ShortCut PMS
Not Yet Recruiting
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07631988
Lead Sponsor Pi-cardia
Conditions Aortic Stenosis Treated With TAVI
Enrollment 150 participants
Start Date 2026-06
Primary Completion 2027-07 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-08