Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05751577

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Aortic Stenosis, Severe Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Unità Sanitaria Locale, Bologna, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAVI WITHOUT ON-SITE SURGERY

Procedure

After randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without on-site surgery

TAVI WITH ON-SITE SURGERY

Procedure

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Secondary efficacy endpoints

    Time frame: 1-year

    All-cause death Cardiovascular death Myocardial infarction Hospital admission for cardiovascular cause Hospital admission for heart failure Cerebrovascular accident Ischemic stroke Hospital admission for pneumonia (± respiratory failure) Need for balloon aortic valvuloplasty for emergent condition Quality of life measured with the Eq-5D and KCCQ-12 scales Time spent on the waiting list before TAVI

  2. Other safety endpoints

    Time frame: 1-year

    Cardiac tamponade Bleeding Kidney failure (requirement for renal replacement therapy) Severe aortic regurgitation (aortic regurgitation according to current guidelines) Multiorgan failure (failure of at least two organ systems) Vascular access site and access related complications Conduction disturbances and arrhythmias Endocarditis Valve thrombosis Valve malpositioning Valve embolization Ectopic valve deployment TAV-in-TAV deployment

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Collaborators

  • Azienda USL Reggio Emilia - IRCCS
  • University Hospital of Ferrara

Registry information

Acronym: TRACS

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Mar 2, 2023
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.