Clinical trial Recruiting at 12 sites Observational Ages 18 and up

Assessing ischemic and bleeding risks after TAVR

Official title: Ischemic And Bleeding Risk Assessment After TAVR (FOCUS ONE Registry)

Run by Niguarda Hospital · NCT06000943 · Data updated 2026-11-12

This study looks at the risks of bleeding and heart problems in patients getting a new heart valve through TAVR to see how to best tailor their blood-thinning treatment.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment2500 (estimated)
SponsorNiguarda Hospital
Academic / other
Locations12 sites (Aalst and 11 other locations)
StatusRecruiting
StartedAugust 1, 2023
Main results expectedNovember 1, 2024
Study endsDecember 15, 2026
Registry record updatedApril 16, 2026
Trial IDNCT06000943 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with severe aortic stenosis who are scheduled to undergo TAVR and can have their antithrombotic therapy adjusted post-procedure.

Probably not a fit

Patients who are on triple antithrombotic therapy at discharge or have a known prognosis of less than one year at the time of TAVR may not benefit from this study.

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

What this trial studies

This observational study evaluates the risks of ischemic and bleeding events in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis. It aims to establish a tailored antithrombotic strategy based on individual patient risk profiles and the type of prosthesis used. The study will analyze data from patients at various surgical risk levels and assess changes in antithrombotic therapy over time. By comparing outcomes, the study seeks to identify optimal treatment approaches to improve patient safety and outcomes.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective antithrombotic therapies for patients undergoing TAVR, reducing the risk of ischemic and bleeding events.

How similar studies have gone: While there have been studies on antithrombotic strategies in TAVR patients, this specific approach of stratifying risks based on surgical profiles is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion criteria

* All patients with severe aortic stenosis undergoing TAVR.
* Availability of changes in antithrombotic therapy at 1 month, 90 days, and 1 year after TAVR.

Exclusion Criteria

* Patients who died during the index procedure
* Patients in triple antithrombotic therapy at discharge
* Patients with a known prognosis less than 1 year at the time of TAVR

Where it's running

  • OLV Hospital
    Aalst, Belgium
    Recruiting
  • Complejo Asistencial Dr. Sótero del Río
    Santiago, Chile
    Recruiting
  • Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
    Prague, Czechia
    Recruiting
  • ASST GOM Niguarda
    Milan, Italia, Italy
    Recruiting
  • Humanitas Research Hospital
    Rozzano, Milano, Italy
    Recruiting
  • IRCCS Policlinico San Donato
    San Donato Milanese, Milano, Italy
    Recruiting
Show 6 more locations
  • IRCCS Ospedale Policlinico San Martino
    Genova, Italy
    Recruiting
  • Ospedale Galeazzi Sant'Ambrogio
    Milan, Italy
    Recruiting
  • San Carlo Hospital
    Potenza, Italy
    Recruiting
  • Azienda Ospedaliera Sant'Andrea
    Roma, Italy
    Recruiting
  • A.O.U. Città della Salute e della Scienza di Torino
    Torino, Italy
    Recruiting
  • Puerto Real University Hospital, Puerto Real
    Cadiz, Spain
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.