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Early Aortic vaLve surgEry Versus wAtchful waitiNg Strategy in Severe Asymptomatic aOrtic reguRgitation

RecruitingNAAges 18 Years - anyAllNa Homolce Hospital
NCT05438862 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The optimal timing of surgical intervention in asymptomatic patients with severe aortic regurgitation remains controversial. As per cardiac magnetic resonance assessment, early surgical treatment will be compared with conventional guideline-based strategy in asymptomatic patients with severe aortic regurgitation.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Chronic asymptomatic aortic regurgitation grade 3 (moderate to severe) and grade 4 (severe) * No indication for the surgical treatment at the time of enrolment * LV ejection fraction \>50% * Absence of more than mild-to-moderate concomitant valve disease or complex congenital heart disease Exclusion Criteria: * Age \<18 years * Clearance Creatinine \<30 mL/min * Contraindication for magnetic resonance (implanted active device, ferromagnetic implant incompatible with magnetic resonance scanner, cerebral aneurysm clip, metallic fragment in the eye or near sensitive tissue) * Pregnancy * Permanent atrial fibrillation.
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What it tests

  • State of art aortic valve surgery
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Where

8 sites
Cardiovascular Center OLV Clinic Aalst
Aalst, Belgium
International Clinical Research Center, St. Anne´s University Hospital Brno
Brno, Czechia
Center of Cardiovascular and Transplant Surgery
Brno, Czechia
University Hospital Hradec Králové
Hradec Králové, Czechia
2nd Department of Internal Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Prague, Czechia
Na Homolce Hospital
Prague, Czechia
Nemocnice AGEL Třinec-Podlesí
Třinec, Czechia
University Clinical Center of Serbia
Belgrade, Serbia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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