Clinical Trial

TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial

Study acronym: TRACS
Active, Not Recruiting
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Summary
The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers with on-site cardiac surgery in terms of all-cause death, stroke and rehospitalization for cardiovascular cause. The primary safety objective is to demonstrate that mortality associated with periprocedural complications actionable by emergent cardiac surgery did not differ between study arms.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-02-21; most recent amendment 2026-04-03.
Status change: Recruiting → Active, Not Recruiting 2026-04-03
Status change: Not Yet Recruiting → Recruiting 2023-05-09
Trial Details
NCT Number NCT05751577
Lead Sponsor Azienda Usl di Bologna
Collaborators: Azienda USL Reggio Emilia - IRCCS, University Hospital of Ferrara
Conditions Aortic Stenosis, Severe
Enrollment 657 participants
Start Date 2023-05-01
Primary Completion 2027-03-31 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-08