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

Comparative Analysis of Standard Surgical Techniques vs. "Y Incision" Technique for Aortic Root Enlargement in Patients With Small Aortic Annulus Undergoing Aortic Valve Replacement: A Randomized Open-Label Controlled Trial (CRYSTAL Trial - Comparative Research of Y-Incision vs. Standard Techniques for Aortic Root EnLargement)

This compares the Y‑incision versus standard surgical enlargement to see if surgeons can implant larger valves and reduce patient‑prosthesis mismatch in adults needing aortic valve replacement who have a small aortic annulus.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Rambam Health Care Campus (other)
• Locations: 1 site (Haifa)
• Trial ID: NCT07368322 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–80 with aortic valve disease requiring AVR who have a small aortic annulus likely to cause moderate or severe patient‑prosthesis mismatch and who are judged suitable for surgery by the heart team are ideal candidates.

Not a fit: Patients without a small annulus where conventional AVR will not cause mismatch, those with prior cardiac surgery, active endocarditis, or severe additional valvular disease requiring other procedures are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, the Y‑incision could allow implantation of larger prosthetic valves, reduce patient‑prosthesis mismatch, and improve hemodynamics and long‑term outcomes.

How similar studies have performed: Early case series and reports of the Y‑incision technique have shown promising ability to accommodate larger valves, but there are no large comparative or randomized trials definitively proving its safety and long‑term benefits.

Eligibility criteria

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 this trial is running

Haifa

• Rambam Health Care Campus — Haifa, Israel (RECRUITING)

Study contacts

• Study coordinator: Nadav Willner, MD

Conditions: Severe Aortic Valve Disease, Aortic Valve Replacement, Small Aortic Annulus, AVR, Aortic Root Enlargement, Y Incision