NCT05751577

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 657 (actual)
• Sponsor: Azienda Usl di Bologna · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

TRACS is an all-comer, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (PROBE). The TRACS trial will involve centers without on-site cardiac surgery, but with experienced operators already performing TAVI at the referring center with on-site cardiac surgery. Thus, participating centers and their study TAVI operators must follow selective criteria for eligibility. Participants will be recruited after Heart Team indication to TAVI procedure. The eligibility of each single patient to the study MUST BE CONFIRMED and VALIDATED by unanimous decision of the Heart Team. Study patients will be randomized in a 2:1 fashion to TAVI procedure performed by the same experienced operators either in the center without on-site cardiac surgery or in the referring center with on-site cardiac surgery.

Conditions

• Aortic Stenosis, Severe

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-05-01
• Primary completion: 2027-03-31
• Completion: 2029-03-31
• First posted: 2023-03-02
• Last updated: 2026-04-08

Locations

14 sites across 1 country: Italy