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Study identifier: NCT07368322 Synced from ClinicalTrials.gov · July 29, 2026
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Comparative Research of Y-Incision vs. Standard Techniques for Aortic Root EnLargement

Condition: Severe Aortic Valve Disease · Aortic Valve Replacement (AVR) · Small Aortic Annulus  ·  Sponsor: willner nadav MD

PhaseNA
Planned participants90
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNo

About this study

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 compare the safety outcomes, hemodynamic performance, and functional capacity of the "Y incision" technique versus standard surgical enlargement techniques in patients with a small aortic annulus undergoing AVR, with particular emphasis on objective functional assessment using cardiopulmonary exercise testing (CPET). Methods: This prospective, randomized, controlled superiority trial will enroll patients with aortic valve disease and a small aortic annulus where conventional AVR is expected to result in moderate or severe PPM. Patients will be randomized 1:1 to either the standard surgical t…

This description comes directly from the study's public registry record.

Talk to the study team

Nadav Willner, MD  ·  +972-50-8845456  ·  n_willner@rmc.gov.il

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Locations (1)

Rambam Health Care CampusHaifa, IsraelRecruiting

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Source record: clinicaltrials.gov/study/NCT07368322