Assessing ischemic and bleeding risks after TAVR
Ischemic And Bleeding Risk Assessment After TAVR (FOCUS ONE Registry)
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 type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Niguarda Hospital Academic / other |
| Locations | 12 sites (Aalst and 11 other locations) |
| Trial ID | NCT06000943 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While there have been studies on antithrombotic strategies in TAVR patients, this specific approach of stratifying risks based on surgical profiles is relatively novel.
Eligibility criteria
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 this trial is running
Aalst and 11 other locations
- 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)
- 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
- Study coordinator: Giuseppe Esposito, MD
- Email: giuseppe.esposito@yahoo.com
- Phone: +393278393131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.