NCT06000943

Ischemic And Bleeding Risk Assessment After TAVR

Name: Clinical Trial NCT06000943
Creator: Niguarda Hospital
Keywords: Aortic Valve Stenosis,Transcatheter Aortic Valve Replacement, Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT, other, clinical trial, Belgium,Chile,Czech,Italy,Spain

Ischemic And Bleeding Risk Assessment After TAVR (FOCUS ONE Registry)

Niguarda Hospital·ClinicalTrials.gov·otherRecruiting

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Study focus

Disease/Condition: Aortic Valve Stenosis,Transcatheter Aortic Valve Replacement
Drug/Device/Intervention: Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT
Study type: Observational
Intervention type: other

Sponsor & location

Primary sponsor: Niguarda Hospital
Location: Aalst,Santiago,Prague,Milano,Rozzano,San Donato Milanese,Genova,Milano,Potenza,Roma,Torino,Cadiz, Belgium,Chile,Czech,Italy,Spain

Timeline & enrollment

Phase: N/A
Start date: Aug 01, 2023
End date: Dec 15, 2024
Enrollment: 2500 participants

Primary outcome

Trend of average daily ischemic risk (ADIR) and average daily bleeding risk (ADBR),Average daily risks (ADRs) in different type of valve prosthesis

Summary

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.

ICD-10 classifications

Aortic (valve) stenosisCongenital stenosis of aortic valveAortic (valve) stenosis with insufficiencyStenosis of aortaAortic valve disorder, unspecified

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06000943
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06000943 through Pure Global AI's free database. This phase not specified trial is sponsored by Niguarda Hospital and is currently Recruiting. The study focuses on Aortic Valve Stenosis,Transcatheter Aortic Valve Replacement. Target enrollment is 2500 participants.

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