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Taking people in ItalyNo phase

Ischemic And Bleeding Risk Assessment After TAVR

Key facts

Who runs it
Niguarda Hospital
Where
Genova, Milan, Potenza, Roma, Rozzano, San Donato Milanese, and Torino, ItalySee the 8 sitesAlso in 4 other countries, 4 sites
Trial code
Status
Recruiting
People taking part
2,500 people, planned
Started
1 Aug 2023
Expected to end
15 Dec 2026
Type of study
Observational, 3 groups
Treatments tested
  • Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT
Record updated
16 April 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

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

Who cannot take part

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

Where in Italy

Also in 4 other countries, 4 sites

  • IRCCS Ospedale Policlinico San MartinoGenova, ItalyContact: Giuseppe Esposito, MDTaking people
  • ASST GOM NiguardaMilan, ItalyContact: Giuseppe Esposito, MDTaking people
  • Ospedale Galeazzi Sant'AmbrogioMilan, ItalyContact: Giuseppe Esposito, MDTaking people
  • San Carlo HospitalPotenza, ItalyContact: Giuseppe Esposito, MDTaking people
  • Azienda Ospedaliera Sant AndreaRoma, ItalyContact: Giuseppe Esposito, MDTaking people
  • Humanitas Research HospitalRozzano, ItalyContact: Giuseppe Esposito, MDTaking people
  • IRCCS Policlinico San DonatoSan Donato Milanese, ItalyContact: Giuseppe Esposito, MDTaking people
  • A.O.U Città della Salute e della Scienza di TorinoTorino, ItalyContact: Giuseppe Esposito, MDTaking people

About the trial

What the trial wants to find out

Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2).

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Giving an established uniform approach towards anticoagulation and antithrombotic therapy after TAVR in the post POPULAR-TAVI era, recent data coming from the analysis of different trials, highlight the relevance of the patient's background on the occurrence of ischemic and bleeding events.

Despite this a targeted antithrombotic strategy remains unexplored and all patients undergoing TAVR without other indication to DAPT or OAC, were currently treated according with the concept of "less is more" (only SAPT or only OAC) regardless the risk level (5-6).

The keys points of the project will be 1) the assessment of ischemic and bleeding risk after TAVR stratified according with antithrombotic therapy and surgical risk; 2) the evaluation of the impact of prostheses type and the complete blood count variables (hemoglobine and platelets) on the daily average ischemic and bleeding risk and 3) the evaluation of the dynamic therapeutic changes after TAVR during the follow up.

The 3 groups in the trial

  • Lower Surgical Risk

    Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)

    Treatment: Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT

  • Intermediate Surgical Risk

    Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)

    Treatment: Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT

  • High Surgical Risk

    Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)

    Treatment: Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Ischemic And Bleeding Risk Assessment After TAVR (FOCUS ONE Registry)
Record updated
16 April 2026