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| Name | Class |
|---|---|
| Azienda USL Reggio Emilia - IRCCS | OTHER_GOV |
| University Hospital of Ferrara | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY | Experimental | 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 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVI WITHOUT ON-SITE SURGERY | Procedure | After randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without on-site surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy endpoints | All-cause death Cardiovascular death Myocardial infarction Hospital admission for cardiovascular cause Hospital admission for heart failure Cerebrovascular accident Ischemic stroke Hospital admission for pneumonia (± respiratory failure) Need for balloon aortic valvuloplasty for emergent condition Quality of life measured with the Eq-5D and KCCQ-12 scales Time spent on the waiting list before TAVI |
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Inclusion Criteria:
AND one of the following:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianmarco Iannopollo, MD | Azienda UnitĂ Sanitaria Locale Bologna, Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda UnitĂ Sanitaria Locale | Bologna | Bologna | 40100 | Italy | ||
| Ospedale San Donato di Arezzo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39505122 | Derived | 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. |
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TRACS is an all-comer, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (PROBE)
| TAVI WITH ON-SITE SURGERY | Procedure | 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 |
|
| 1-year |
| Other safety endpoints | Cardiac tamponade Bleeding Kidney failure (requirement for renal replacement therapy) Severe aortic regurgitation (aortic regurgitation according to current guidelines) Multiorgan failure (failure of at least two organ systems) Vascular access site and access related complications Conduction disturbances and arrhythmias Endocarditis Valve thrombosis Valve malpositioning Valve embolization Ectopic valve deployment TAV-in-TAV deployment | 1-year |
| 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 |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
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