NCT05788770

Preoperative CT-imaging With Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial

Name: Clinical Trial NCT05788770
Creator: Romy Hegeman
Keywords: Aortic Valve Stenosis, FEops HEARTGuide, other, clinical trial, Austria,Netherlands

Romy Hegeman·ClinicalTrials.gov·otherRecruiting

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Study focus

Disease/Condition: Aortic Valve Stenosis
Drug/Device/Intervention: FEops HEARTGuide
Study type: Interventional
Intervention type: other

Sponsor & location

Primary sponsor: Romy Hegeman
Funder: St. Antonius Hospital
Location: Vienna,Nieuwegein, Austria,Netherlands

Timeline & enrollment

Phase: N/A
Start date: Apr 06, 2022
End date: Dec 31, 2024
Enrollment: 454 participants

Primary outcome

Mild to severe paravalvular regurgitation

Summary

Combining routine preoperative CT imaging with patient-specific computer modelling predicts the interaction between different sizes of transcatheter aortic valve replacement devices at different implantation depths and the patient's unique anatomy (including post-implantation deformation) allowing preoperative evaluation of the risk for paravalvular leakage and conduction disorders.  The objective of this randomized controlled trial is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguide™) adequately predicts procedural outcomes in TAVR procedures, whether it leads to changes of preoperative decisions and whether or not this leads to improved outcome in TAVR procedures.

ICD-10 classifications

Aortic (valve) stenosisAortic (valve) stenosis with insufficiencyCongenital stenosis of aortic valveStenosis of aortaRheumatic aortic stenosis

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05788770
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05788770 through Pure Global AI's free database. This phase not specified trial is sponsored by Romy Hegeman and is currently Recruiting. The study focuses on Aortic Valve Stenosis. Target enrollment is 454 participants.

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