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

Last updated: April 5, 2024
Sponsor: Azienda Usl di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

TAVI WITH ON-SITE SURGERY

TAVI WITHOUT ON-SITE SURGERY

Clinical Study ID

NCT05751577
40-2023-SPER-AUSLBO
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 HeartTeam, 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/oradhering 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

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

Study Design

Total Participants: 566
Treatment Group(s): 2
Primary Treatment: TAVI WITH ON-SITE SURGERY
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
May 01, 2028

Study 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.

Connect with a study center

  • Ospedale San Donato di Arezzo

    Arezzo,
    Italy

    Active - Recruiting

  • Ospedale Cardinal Massaia di Asti

    Asti,
    Italy

    Active - Recruiting

  • Ospedale degli Infermi di Biella

    Biella,
    Italy

    Active - Recruiting

  • Azienda Unità Sanitaria Locale

    Bologna, 40100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria di Ferrara

    Ferrara,
    Italy

    Active - Recruiting

  • Ospedale Misericordia di Grosseto

    Grosseto,
    Italy

    Active - Recruiting

  • Azienda ULSS 3 Serenissima, Ospedale di Mirano

    Mirano,
    Italy

    Active - Recruiting

  • Ospedale Guglielmo da Saliceto di Piacenza

    Piacenza,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Reggio Emilia

    Reggio Emilia,
    Italy

    Active - Recruiting

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