TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
Azienda Usl di Bologna
566 participants
May 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria15
- 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 Criteria5
- Unsuitable for transfemoral TAVI
- Emergent TAVI
- Noncardiovascular comorbidity reducing life expectancy to \<1 year
- Any factor precluding 1-year follow-up
- Refusal informed consent
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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
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT05751577