Actively Recruiting
Ischemic And Bleeding Risk Assessment After TAVR
Led by Niguarda Hospital · Updated on 2026-04-16
2500
Participants Needed
12
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2). 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.
CONDITIONS
Official Title
Ischemic And Bleeding Risk Assessment After TAVR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients with severe aortic stenosis undergoing TAVR.
- Availability of changes in antithrombotic therapy at 1 month, 90 days, and 1 year after TAVR.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 12 locations
1
OLV Hospital
Aalst, Belgium
Actively Recruiting
2
Complejo Asistencial Dr. Sótero del Río
Santiago, Chile
Actively Recruiting
3
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, Czechia, 10034
Actively Recruiting
4
ASST GOM Niguarda
Milan, Italia, Italy, 20162
Actively Recruiting
5
Humanitas Research Hospital
Rozzano, Milano, Italy, 20089
Actively Recruiting
6
IRCCS Policlinico San Donato
San Donato Milanese, Milano, Italy
Actively Recruiting
7
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Actively Recruiting
8
Ospedale Galeazzi Sant'Ambrogio
Milan, Italy
Actively Recruiting
9
San Carlo Hospital
Potenza, Italy
Actively Recruiting
10
Azienda Ospedaliera Sant'Andrea
Roma, Italy
Actively Recruiting
11
A.O.U. Città della Salute e della Scienza di Torino
Torino, Italy
Actively Recruiting
12
Puerto Real University Hospital, Puerto Real
Cadiz, Spain
Actively Recruiting
Research Team
G
Giuseppe Esposito, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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