TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
NCT ID: NCT05751577
Last Updated: 2024-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
566 participants
INTERVENTIONAL
2023-05-01
2028-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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EXPERIMENTAL ARM: 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
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
CONTROL ARM: 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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Emergent TAVI
* Noncardiovascular comorbidity reducing life expectancy to \<1 year
* Any factor precluding 1-year follow-up
* Refusal informed consent
18 Years
ALL
No
Sponsors
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Azienda USL Reggio Emilia - IRCCS
OTHER_GOV
Università degli Studi di Ferrara
OTHER
University Hospital of Ferrara
OTHER
Azienda Usl di Bologna
OTHER_GOV
Responsible Party
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Locations
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Ospedale San Donato di Arezzo
Arezzo, , Italy
Ospedale Cardinal Massaia di Asti
Asti, , Italy
Ospedale degli Infermi di Biella
Biella, , Italy
Azienda Unità Sanitaria Locale
Bologna, , Italy
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, , Italy
Ospedale Misericordia di Grosseto
Grosseto, , Italy
Azienda ULSS 3 Serenissima, Ospedale di Mirano
Mirano, , Italy
Ospedale Guglielmo da Saliceto di Piacenza
Piacenza, , Italy
Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Leonardo Bolognese
Role: primary
Carlo Tumscitz
Role: primary
Salvatore Saccà
Role: primary
References
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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.
Other Identifiers
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40-2023-SPER-AUSLBO
Identifier Type: -
Identifier Source: org_study_id
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