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ACTIVE NOT RECRUITING
NCT05751577
NA

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

Sponsor: Azienda Usl di Bologna

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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

PROCEDURE

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