TAVI without on-site heart surgery: can selected centers do it safely?

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

TRACS-PRIME is a randomized, multicenter study comparing TAVI performed in centers without on-site cardiac surgery to centers with on-site surgical support. Eligible patients have severe symptomatic aortic stenosis and a Heart Team-indicated indication for TAVI, plus additional risk-enrichment criteria. Procedures are conducted by experienced TAVI operators using standard care and strict safety protocols with established transfer pathways. The primary goal is to show non-inferiority of clinical outcomes at 1 year between the two settings. The study builds on prior pilot work that supported feasibility under organized protocols and safeguards.

Why it matters

Who can join: the full rules

Inclusion criteria

1. Severe aortic stenosis
2. Indication to TAVI confirmed by the Heart Team

AND one of the following enrichment criteria:

1. Prohibitive operative risk
2. High surgical risk as defined as STS score \>8%
3. Porcelain aorta or severely atherosclerotic aorta
4. Frailty/Reduced physical performance
5. Severe liver disease/cirrhosis
6. Hostile chest and/or internal mammalian artery or other critical conduit(s) crossing midline and/or adhering to the posterior table of the sternum
7. Severe pulmonary hypertension and/or severe right ventricular dysfunction
8. Age ≥85 years
9. Severe Chronic Obstructive Pulmonary Disease (COPD) The criteria listed above qualify the patient for eligibility in the study if present immediately after the heart team has indicated TAVI. However, this does not exclude patients without these criteria from entering the study if the heart team's evaluation still considers their risk/benefit profile appropriate for inclusion in the protocol.

Exclusion criteria

1. Unsuitable for transfemoral TAVI
2. Emergent TAVI
3. Non-cardiovascular comorbidity reducing life expectancy to \<1 year
4. Any factor precluding 1-year follow-up
5. Refusal of informed consent

Where it's running

• Ospedale "L. Bonomo" - Andria - ASL Barletta Andria Trani
  Andria, Italy Recruiting
• Ospedale San Donato
  Arezzo, Italy Recruiting
• Ospedale Maggiore CA Pizzardi, AUSL di Bologna
  Bologna, Italy Recruiting
• Ospedale Misericordia di Grosseto
  Grosseto, Italy Recruiting
• Ospedale Regionale San Salvatore
  L’Aquila, Italy Recruiting
• Ospedale di Mirano
  Mirano, Italy Recruiting

Study contacts

• Principal investigator: Gianluca Campo, MD — University Hospital of Ferrara
• Study coordinator: Gianluca Campo, MD
• Email: cmpglc@unife.it
• Phone: 0532236450

Similar studies

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

• Exercise and nutrition support before and after TAVI for older adults with aortic stenosis

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• Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI

  This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.

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• Systematic 14-day ambulatory heart monitoring after TAVI

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  Recruiting Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Québec, Quebec · NCT07739316

• Echo-AVCS: Drawing AI-powered clues from heart scans to confirm severe aortic stenosis

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  Recruiting at 4 sites Azienda Ospedaliera "Sant'Andrea" · Bologna and 4 other locations · NCT07620925

• Willem AI for early detection of aortic stenosis from a 12‑lead ECG

  This project will test whether the Willem AI can detect aortic stenosis from routine 12‑lead ECGs in adults.

  Recruiting at 2 sites Idoven 1903 S.L. · Bonn and 1 other locations · NCT07479992

• Monitoring progression of chronic cardiovascular conditions

  This project will collect wearable physiologic data from adults with cardiovascular conditions to see how their heart disease changes over time.

  Recruiting Prolaio · Chicago, Illinois · NCT07420907

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.