Clinical Research Directory
Browse clinical research sites, groups, and studies.
TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
Sponsor: Azienda Usl di Bologna
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
657
Start Date
2023-05-01
Completion Date
2029-03-31
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
TAVI WITHOUT ON-SITE SURGERY
After randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without on-site surgery
TAVI WITH ON-SITE SURGERY
After randomization, the patient will immediately be placed on the waiting list of the referring center with on-site cardiac surgery. Study TAVI operators of the participating center will perform the TAVI procedure in the hospital with on-site surgery according to the waiting list schedule of the latter
Locations (14)
Azienda Unità Sanitaria Locale
Bologna, Bologna, Italy
Ospedale San Donato di Arezzo
Arezzo, Italy
Ospedale Cardinal Massaia di Asti
Asti, Italy
Ospedale degli Infermi di Biella
Biella, Italy
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, Italy
Ospedale "Morgagni - Pierantoni" di Forlì
Forlì, Italy
Ospedale Misericordia di Grosseto
Grosseto, Italy
Azienda ULSS 3 Serenissima, Ospedale di Mirano
Mirano, Italy
Ospedale Civile di Baggiovara
Modena, Italy
Ospedale Guglielmo da Saliceto di Piacenza
Piacenza, Italy
Ospedale Santa Maria delle Croci
Ravenna, Italy
Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, Italy
Ospedale Infermi di Rimini
Rimini, Italy
Ospedale Civile di Venezia SS Giovanni e Paolo
Venezia, Italy