TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery
Key facts
- Where
- Andria, Arezzo, Bologna, Ferrara, Grosseto, L’Aquila, Mirano, Ravenna, Rimini, Venezia, and Verona, ItalySee the 11 sites
Where in Italy
- Ospedale "L. Bonomo" - Andria - ASL Barletta Andria TraniAndria, ItalyContact: Claudio Larosa, MDTaking people
- Ospedale San DonatoArezzo, ItalyContact: Matteo Reccia, MDTaking people
- Ospedale Maggiore CA Pizzardi, AUSL di BolognaBologna, ItalyContact: Gianni Casella, MDTaking people
- Azienda Ospedaliero Universitaria di FerraraFerrara, ItalyContact: Gianluca, CampoNot yet recruiting
- Ospedale Misericordia di GrossetoGrosseto, ItalyContact: Andrea Picchi, MDTaking people
- Ospedale Regionale San SalvatoreL’Aquila, ItalyContact: Livio Giuliani, MDTaking people
- Ospedale di MiranoMirano, ItalyContact: Salvatore SaccàTaking people
- Ospedale Santa Maria delle Croci, AUSL RomagnaRavenna, ItalyContact: Carolina Moretti, MDTaking people
- Ospedale degli Infermi di RiminiRimini, ItalyContact: Caterina Cavazza, MDTaking people
- Ospedale Ss. Giovanni e PaoloVenezia, ItalyContact: Giuseppe GrassiTaking people
- Ospedale Sacro Cuore Don Calabria - NegrarVerona, ItalyContact: Giulio Molon, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital of Ferrara
- Trial code
- NCT07604402
- Record updated
- 21 August 2026
- Original description
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.Read full original descriptionShow less
TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery Broadened Access
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.
Inclusion: Severe aortic stenosis; Indication to TAVI confirmed by the Heart Team; AND one of the following enrichment criteria:; Prohibitive operative risk; High surgical risk as defined as STS score >8%; Porcelain aorta or severely atherosclerotic aorta; Frailty/Reduced physical performance; Severe liver disease/cirrhosis; Hostile chest and/or internal mammalian artery or other critical conduit(s) crossing midline and/or adhering to the posterior table of the sternum; Severe pulmonary hypertension and/or severe right ventricular dysfunction; Age ≥85 years; Severe Chronic Obstructive Pulmonary Disease (COPD) The criteria listed above qualify the patient for eligibility in the study if present immediately after the heart team has indicated TAVI. However, this does not exclude patients without these criteria from entering the study if the heart team's evaluation still considers their risk/benefit profile appropriate for inclusion in the protocol.
Exclusion: Unsuitable for transfemoral TAVI; Emergent TAVI; Non-cardiovascular comorbidity reducing life expectancy to <1 year; Any factor precluding 1-year follow-up; Refusal of informed consent.