Actively Recruiting

Age: 18Years +
All Genders
NCT06000943

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here