RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Unsuitable for transfemoral TAVI - Emergent TAVI - Noncardiovascular comorbidity reducing life expectancy to \<1 year - Any factor precluding 1-year follow-up - Refusal willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

PROCEDURE

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

PROCEDURE

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

Locations (9)

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