TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
Key facts
- Who runs it
- Azienda Usl di Bologna
- Where
- Italy14 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 657 people enrolled
- Started
- 1 May 2023
- Expected to end
- 31 Mar 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- TAVI WITHOUT ON-SITE SURGERY
- TAVI WITH ON-SITE SURGERY
- Record updated
- 8 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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 cannot take part
- Unsuitable for transfemoral TAVI
- Emergent TAVI
- Noncardiovascular comorbidity reducing life expectancy to <1 year
- Any factor precluding 1-year follow-up
- Refusal informed consent
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERYTreatment being tested
After randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without on-site surgery
Treatment: TAVI WITHOUT ON-SITE SURGERY
- CONTROL ARM: TAVI WITH ON-SITE SURGERYExisting treatment, for comparison
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
Treatment: TAVI WITH ON-SITE SURGERY
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 8 April 2026