TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Azienda Usl di Bologna
- Enrollment
- 566
- Locations
- 23
- Primary Endpoint
- Primary safety endpoint
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
TRACS is an all-comer, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (PROBE)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Primary safety endpoint
Time Frame: 1-year
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
Primary efficacy endpoint
Time Frame: 1-year
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
Secondary Outcomes
- Secondary efficacy endpoints(1-year)
- Other safety endpoints(1-year)