Transcatheter aortic valve implantation with or without on-site cardiac surgery

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

This study is testing whether getting a heart valve replacement without immediate access to heart surgery is as safe and effective as having it done where surgery is available for patients needing this treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 566 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Azienda Usl di Bologna (Government)
• Locations: 9 sites (Arezzo and 8 other locations)
• Trial ID: NCT05751577 on ClinicalTrials.gov

What this trial studies

The TRACS trial aims to compare the outcomes of transcatheter aortic valve implantation (TAVI) performed in centers without on-site cardiac surgery to those performed in centers with on-site surgery. This multicenter, randomized trial will involve experienced operators and will assess all-cause death, stroke, and rehospitalization for cardiovascular causes. Patients will be recruited based on a Heart Team's indication for TAVI, and their eligibility will be confirmed by a unanimous decision of the team. Participants will be randomized in a 2:1 ratio to receive TAVI in either setting.

Who should consider this trial

Good fit: Ideal candidates include patients with severe aortic stenosis who are either inoperable or at high surgical risk as determined by the Heart Team.

Not a fit: Patients unsuitable for transfemoral TAVI or those requiring emergent procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safe and effective option for patients with severe aortic stenosis who are at high surgical risk.

How similar studies have performed: Other studies have shown promising results with TAVI procedures, but this specific comparison of settings is novel.

Eligibility criteria

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

Where this trial is running

Arezzo and 8 other locations

• Ospedale San Donato di Arezzo — Arezzo, Italy (Recruiting)
• Ospedale Cardinal Massaia di Asti — Asti, Italy (Recruiting)
• Ospedale degli Infermi di Biella — Biella, Italy (Recruiting)
• Azienda Unità Sanitaria Locale — Bologna, Italy (Recruiting)
• Azienda Ospedaliero Universitaria di Ferrara — Ferrara, Italy (Recruiting)
• Ospedale Misericordia di Grosseto — Grosseto, Italy (Recruiting)
• Azienda ULSS 3 Serenissima, Ospedale di Mirano — Mirano, Italy (Recruiting)
• Ospedale Guglielmo da Saliceto di Piacenza — Piacenza, Italy (Recruiting)
• Azienda Ospedaliera di Reggio Emilia — Reggio Emilia, Italy (Recruiting)

Study contacts

• Study coordinator: Gianmarco Iannopollo, Md

Conditions Aortic Stenosis, Severe