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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2500 (estimated) |
| Sponsor | Niguarda Hospital Academic / other |
| Locations | 12 sites (Aalst and 11 other locations) |
| Status | Recruiting |
| Started | August 1, 2023 |
| Main results expected | November 1, 2024 |
| Study ends | December 15, 2026 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT06000943 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
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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
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluation of the Point-Guard device during heart valve replacement
This study is testing a new device called Point-Guard to see if it can help prevent brain problems during heart valve replacement surgery.
-
Evaluating the SAPIEN 3 Ultra RESILIA Valve for Aortic Stenosis
This study tests how well the new SAPIEN 3 Ultra RESILIA valve works for people with severe aortic stenosis who are getting a heart valve replacement, by checking its performance over the next 10 years.
-
Evaluating coronary re-engagement after TAVR with a Navitor valve
This study is testing if a new way of placing a heart valve during TAVR can help doctors still access the coronary arteries for patients who have both aortic stenosis and coronary artery disease.
-
Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring
This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.
-
SYMmetric Valve expansion to reduce hypoattenuated leaflet thickening after balloon-expandable TAVI
This trial tests whether the Double-TAP post-dilatation strategy can reduce HALT and improve valve function in patients 70 or older undergoing balloon-expandable TAVI.
-
Vericiguat to slow calcific aortic valve narrowing
This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.