Y‑incision versus standard aortic root enlargement for people with a small aortic annulus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults with severe aortic valve disease and a small aortic annulus who are candidates for surgical aortic valve replacement. Participants receive either the Y‑incision aortic root enlargement technique or a standard enlargement method during AVR, with operative details and valve sizes recorded. Key outcomes include perioperative safety, implanted prosthesis size, echocardiographic hemodynamic measures, rates of patient‑prosthesis mismatch, and functional capacity over follow‑up. The outcomes in the two groups are compared to determine whether the Y‑incision provides better hemodynamics and clinical results than standard techniques.

Why it matters

Who can join: the full rules

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

Where it's running

• Rambam Health Care Campus
  Haifa, Israel Recruiting

Study contacts

• Study coordinator: Nadav Willner, MD
• Email: n_willner@rmc.gov.il
• Phone: +972-50-8845456

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.