TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
TRACS
1 other identifier
interventional
657
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
April 8, 2026
April 1, 2026
3.9 years
February 21, 2023
April 3, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Primary efficacy endpoint
1-year cumulative occurrence of all-cause death, stroke and hospital readmission for CV cause To test if the outcome of TAVI procedures performed by experienced operators in the center without onsite cardiac surgery is non inferior to that of TAVI procedures performed by the same team in the center with on-site cardiac surgery
1-year
Primary safety endpoint
To test whether mortality due to periprocedural complications actionable by emergent cardiac surgery differs between the TAVI procedures performed in the center without on-site cardiac surgery and the TAVI procedures performed by the same team in the center with on-site cardiac surgery
1-year
Secondary Outcomes (2)
Secondary efficacy endpoints
1-year
Other safety endpoints
1-year
Study Arms (2)
EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY
EXPERIMENTALAfter randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without on-site surgery
CONTROL ARM: TAVI WITH ON-SITE SURGERY
ACTIVE COMPARATORAfter 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
Interventions
After randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without 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
Eligibility Criteria
You may qualify if:
- Severe aortic stenosis
- Indication to TAVI confirmed by the Study Heart Team
- AND one of the following:
- Inoperable due to prohibitive operative risk
- High surgical risk as defined as STS score \>8%
- The presence of at least one clinical factor that, by unanimous judgment of the Study Heart Team, compromises the benefit/risk ratio in the case of emergent cardiac surgery:
- Porcelain aorta or severely atherosclerotic aorta
- Frailty/Reduced physical performance
- Cognitive impairment, dementia, or Parkinson's disease
- Severe liver disease/cirrhosis
- Hostile chest
- Internal mammalian artery or other critical conduit(s) crossing midline and/or adhering to the posterior table of the sternum
- Severe pulmonary hypertension and/or severe right ventricular dysfunction
- Severe Chronic Obstructive Pulmonary Disease (COPD)
- Age ≥85 years
You may not qualify if:
- Unsuitable for transfemoral TAVI
- Emergent TAVI
- Noncardiovascular comorbidity reducing life expectancy to \<1 year
- Any factor precluding 1-year follow-up
- Refusal informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azienda Usl di Bolognalead
- Azienda USL Reggio Emilia - IRCCScollaborator
- University Hospital of Ferraracollaborator
Study Sites (14)
Azienda Unità Sanitaria Locale
Bologna, Bologna, 40100, 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
Related Publications (1)
Iannopollo G, Cocco M, Leone A, Sacca S, Mangino D, Picchi A, Reccia MR, Fineschi M, Meliga E, Audo A, Nobile G, Tumscitz C, Penzo C, Saia F, Rubboli A, Moretti C, Vignali L, Niccoli G, Cimaglia P, Rognoni A, Aschieri D, Iaccarino D, Ottani F, Cavazza C, Varbella F, Secco GG, Bolognese L, Limbruno U, Guiducci V, Campo G, Casella G. Transcatheter aortic-valve implantation with or without on-site cardiac surgery: The TRACS trial. Am Heart J. 2025 Feb;280:7-17. doi: 10.1016/j.ahj.2024.10.019. Epub 2024 Nov 4.
PMID: 39505122DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gianmarco Iannopollo, MD
Azienda Unità Sanitaria Locale Bologna, Bologna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- TRACS is an all-comer, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (PROBE)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2023
First Posted
March 2, 2023
Study Start
May 1, 2023
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2029
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share