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

NCT05751577 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 657

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis, Severe

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

Sponsors & Collaborators

  • Azienda USL Reggio Emilia - IRCCS

    collaborator OTHER_GOV

  • University Hospital of Ferrara

    collaborator OTHER

  • Azienda Usl di Bologna

    lead OTHER_GOV

Principal Investigators

  • Gianmarco Iannopollo, MD · Azienda Unità Sanitaria Locale Bologna, Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2027-03-31
Completion
2029-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05751577 on ClinicalTrials.gov