TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery

TRACS-PRIME is a prospective, randomized, multicenter clinical trial evaluating whether transcatheter aortic valve implantation (TAVI) can be performed safely and effectively in selected hospitals without on-site cardiac surgery, when appropriate patient selection, experienced operators, advanced imaging, and established transfer pathways are available. The study will include patients with severe symptomatic aortic stenosis who have an indication for TAVI confirmed by a multidisciplinary Heart Team. Eligible patients will be randomized to undergo TAVI either in a center without on-site cardiac surgery or in a center with on-site cardiac surgery. All procedures will be performed according to current standards of care by experienced TAVI operators. The main purpose of the study is to determine whether TAVI performed in centers without on-site cardiac surgery is not inferior to TAVI performed in centers with on-site cardiac surgery with respect to clinical outcomes at 1 year. The primary clinical outcome includes death from any cause, stroke, or hospitalization related to the procedure or the implanted valve. The study will also assess safety outcomes, including valve-related death and major procedural or technical complications. Participants will be followed after hospital discharge to assess clinical events, safety, and longer-term outcomes. An independent committee blinded to treatment allocation will review clinical events, and an independent Data Safety Monitoring Board will monitor patient safety during the trial.

NCT Number	NCT07604402
Lead Sponsor	University Hospital of Ferrara Collaborators: Consorzio Futuro in Ricerca
Conditions	Aortic Stenosis
Enrollment	1,612 participants
Start Date	2026-05-25
Primary Completion	2030-05-25 (estimated)
Study Completion	2034-05-25 (estimated)
Updated on ClinicalTrials.gov	2026-05-29