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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Gianmarco Iannopollo, Md
• Email: gianmarco.iannopollo@ausl.bologna.it
• Phone: 0513138704

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Imaging data collection for patients undergoing Transcatheter Aortic Valve Implantation

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• Exercise testing using cardiac MRI for patients with severe aortic stenosis

  This study is testing how patients with severe aortic stenosis respond to exercise using advanced heart imaging to help doctors make better treatment choices before they get a heart valve replacement.

  Recruiting University of Göttingen · Göttingen · NCT06129799

• SAPIEN X4 Transcatheter Heart Valve safety and effectiveness in severe aortic stenosis

  This study tests the safety and effectiveness of the Edwards SAPIEN X4/X4S transcatheter heart valve in patients with symptomatic, severe aortic stenosis.

  Recruiting at 31 sites Edwards Lifesciences · La Jolla, California and 64 other locations · NCT05172960

• Aortic valve replacement using SAPIEN 3 for failing bioprosthetic valves

  This study is testing if the SAPIEN 3 heart valves can safely help patients with failing bioprosthetic aortic valves feel better.

  Recruiting at 30 sites Edwards Lifesciences · Phoenix, Arizona and 50 other locations · NCT03003299

• Registry of Transcatheter Aortic Valve Treatments at a Italian Center

  This registry tests how safe and effective transcatheter valve procedures are in adults with severe aortic stenosis treated at a single Italian center.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Pavia · NCT07596394

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.