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New 'Y Incision' heart surgery could let doctors fit larger valves in small hearts
NCT ID NCT07368322
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new surgical technique called the 'Y incision' for people with a small aortic annulus (the ring where the heart valve sits) who need aortic valve replacement. The standard methods often limit how large a replacement valve can be placed, which can lead to poor blood flow. The new technique aims to allow a much larger valve to be implanted. The trial will compare safety, heart function, and exercise ability between the two approaches in 90 adults over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Y incision surgical technique
- What this could lead to
- If successful, this technique could allow surgeons to implant larger heart valves in patients with a small aortic annulus, potentially improving blood flow and reducing complications after valve replacement.
- What could go wrong
- This is a relatively small, early-stage trial with only 90 participants. The new technique is more complex and may carry higher risks of bleeding or other surgical complications compared to standard methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rambam Health Care Campus
RECRUITINGHaifa, 210961, Israel