Clinical trial NCT05751577: TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
Official title: TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Stenosis, Severe
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
Collaborators: name: Azienda USL Reggio Emilia - IRCCS
name: Università degli Studi di Ferrara
name: University Hospital of Ferrara
First posted: 2023-03-02
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Unsuitable for transfemoral TAVI
* Emergent TAVI
* Noncardiovascular comorbidity reducing life expectancy to \<1 year
* Any factor precluding 1-year follow-up
* Refusal informed consent

Primary outcomes:
measure: Primary efficacy endpoint
timeFrame: 1-year
measure: Primary safety endpoint
timeFrame: 1-year
Secondary outcomes:
measure: Secondary efficacy endpoints
timeFrame: 1-year
measure: Other safety endpoints
timeFrame: 1-year
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Ospedale San Donato di Arezzo
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia di Asti
city: Biella
country: Italy
facility: Ospedale degli Infermi di Biella
city: Bologna
country: Italy
facility: Azienda Unità Sanitaria Locale
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara
city: Grosseto
country: Italy
facility: Ospedale Misericordia di Grosseto
city: Mirano
country: Italy
facility: Azienda ULSS 3 Serenissima, Ospedale di Mirano
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto di Piacenza
city: Reggio Emilia
country: Italy
facility: Azienda Ospedaliera di Reggio Emilia
Study officials:
References: