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

Study acronym: TRACS
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: May 1, 2026 to Mar 31, 2027v6 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 566 to confirmed 657
    • Study sites: 9 to 14
    • Study completion date: May 1, 2028 to Mar 31, 2029
    • Collaborators: 3 to 2
  2. Enrollment target: 520 to 566
    • Study sites: 1 to 9
    • Collaborators: 11 to 3
    v5
  3. Collaborators: 3 to 11v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  5. Primary completion date: Mar 1, 2024 to May 1, 2026
    • Start date: Mar 1, 2023 to May 1, 2023
    • Study completion date: Mar 1, 2024 to May 1, 2028
    • Collaborators expanded, about 15 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05751577
Lead Sponsor Azienda Usl di Bologna
Collaborators: Azienda USL Reggio Emilia - IRCCS, University Hospital of Ferrara
Conditions
(from sponsor)		 Aortic Stenosis, Severe
Related terms Aortic Valve Stenosis
Enrollment 657 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov