U.S., May 23 -- ClinicalTrials.gov registry received information related to the study (NCT07604402) titled 'TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery' on May 17.
Brief Summary: 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 ...