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Comparative Research of Y-Incision vs. Standard Techniques for Aortic Root EnLargement

RecruitingNAAges 18 Years - 80 YearsAllwillner nadav MD
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In plain words

What the trial is, and whether it could suit you

Abstract Background: Aortic valve replacement (AVR) is crucial for patients with severe aortic valve disease. However, managing those with a small aortic annulus (SAA, i.e., annulus diameter \< 22 mm) is challenging because implanting a small prosthesis can result in patient-prosthesis mismatch (PPM), suboptimal hemodynamic outcomes, and reduced long-term survival. Traditional surgical techniques for aortic root enlargement (ARE), such as the Nicks and Manougian procedures, have significant limitations, typically allowing enlargement of only one to two prosthesis sizes and involving complex reconstructive procedures. The novel "Y incision" technique by Bo Yang offers a promising alternative, allowing implantation of valves up to five sizes larger than the native annulus, but it lacks comprehensive comparative data on its safety, efficacy, and functional outcomes. Aim: This study aims to

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18-80 years. * Patients must have signed and dated an ICF in accordance with regulatory and institutional guidelines before any protocol-related procedures and must be willing and able to comply with scheduled visits. * Diagnosed with aortic valve disease requiring aortic valve replacement. * Patients with small aortic annulus relative to body size where conventional AVR result in moderate or severe PPM (defined as cases where the largest prosthesis that can be implanted in the native annulus would provide a predicted iEOA ≤0.85 cm²/m² for BMI \<30, or ≤0.70 cm²/m² for BMI ≥30), based on manufacturer specifications and patient BSA). * Suitable candidates for surgery as determined by the heart team. Exclusion Criteria: 1. Patients for whom conventional AVR without root enlargement is not expected to result in patient-prosthesis mismatch. 2. Prior cardiac surgery. 3. Severe concomitant valvular disease requiring additional procedures. 4. Active endocarditis. 5. Severe chronic lung disease 6. Pre-existing lower limb deficits or any other medical comorbidities that interfere significantly with gait or the ability to perform exercise testing on a bicycle ergometer 7. Severe left ventricular dysfunction (LVEF \< 30%). 8. Contraindications to surgery. 9. Concurrent active treatment in another clinical trial
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What it tests

  • Y incision Technique (YIT)
  • Standard surgical enlargement techniques
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Where

1 site
Rambam Health Care Campus
Haifa, Israel
🤝 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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