U.S., June 9 -- ClinicalTrials.gov registry received information related to the study (NCT07631988) titled 'The ShortCut Post-Market Study' on May 12.
Brief 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...