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Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry)

Recruitingn/aAges 18 Years - anyAllUniversity of Parma
NCT03143361 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life-expectancy. Recent randomized trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared to traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the "real clinical world". Technological improvements have recently allowed the development of minimally invasive surgical accesses and the use of sutureless valves, but their impact on the clinical scenario is difficult to assess because of the monocentric design of published studies and limited sample-size. A prospective multicentre registry including all patients referred for a surgical treatment of SAVS (traditional, through full-sternotomy; minimally-invasive; or transcatheter;

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📋 Eligibility rules (as published)
Inclusion criteria * Age \>18 yy * Isolated SAVS with or without concomitant aortic valve regurgitation * Isolated prosthetic aortic dysfunction * SAVS + coronary artery disease (CAD) * Prosthetic aortic dysfunction + CAD * Elective, urgent and emergent procedures * Endocarditic aetiology Exclusion criteria * Patients undergoing concomitant mitral valve surgery, or tricuspid valve surgery, or aortic surgery (i.e. composite aortic valve and ascending aorta replacement with or without circulatory arrest), or atrial fibrillation surgery, or any other associated cardiac surgical procedure (with the exception of CABG) * Concomitant aortic root procedure (i.e. Bentall operation, David operation, homografts, autografts) * SAVR with techniques of aortic annular enlargement * Porcelain aorta * Pure aortic valve regurgitation * Percutaneous TAVR requiring surgical cut-down (i.e. failure to comply with a full percutaneous approach, thus configuring a "hybrid procedure") * Patient refusal
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What it tests

  • Aortic valve replacement
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Where

1 site
University of Verona
Verona, Italy
🤝 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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