Aortic valve sizing: comparing CT scan measurements with measurements taken during surgery for people having surgical aortic valve replacement
Intraoperative Assessment Versus Preoperative Multidetector Computed Tomography (MDCT) for Aortic Valve Annular Sizing in Surgical Aortic Valve Replacement (SAVR)"
This will see if CT scan measurements match the aortic valve sizes surgeons measure during surgical aortic valve replacement in adults with severe aortic stenosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maria Cecilia Hospital Academic / other |
| Locations | 1 site (Cotignola, Ravenna) |
| Trial ID | NCT07125469 on ClinicalTrials.gov |
What this trial studies
This single-center interventional protocol compares aortic annulus measurements from preoperative CT scans with intraoperative measurements taken using standard surgical sizing tools in adults undergoing SAVR for isolated severe aortic stenosis. CT-derived dimensions will also be used to propose theoretical sizes for two types of TAVR prostheses to examine how imaging-based sizing aligns with surgical practice. Eligible patients meet 2023 ESC/EACTS criteria for SAVR, while those with bicuspid valves, significant regurgitation, multivalvular disease, prior valve surgery, aortic root/ascending aneurysm, or severe renal dysfunction are excluded. The study quantifies differences between modalities and looks for factors linked to sizing mismatch.
Who should consider this trial
Good fit: Adults (age ≥18) with isolated severe aortic stenosis who are candidates for surgical aortic valve replacement under current 2023 ESC/EACTS guidelines and can provide informed consent.
Not a fit: Patients with bicuspid aortic valves, moderate-to-severe aortic regurgitation, multivalvular disease, redo SAVR, ascending aorta aneurysm or root enlargement, or severe kidney disease (eGFR <30) are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could improve preoperative valve sizing and reduce mismatches between planned and implanted prostheses, helping surgeons choose the right valve size.
How similar studies have performed: Previous comparisons of CT-based sizing with intraoperative and TAVR sizing have shown CT can be accurate but also report discrepancies, so applying these comparisons specifically to SAVR remains only partly explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patient age 18 years or older All patients with isolated severe Aortic Stenosis (AS) considered eligible for Surgical Aortic Valve Replacement (SAVR) according to the current 2023 European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines for management of Valvular Heart Disease (reference 8) will be enrolled. Patient is willing to comply with study procedures and is available to return to the center for follow-up visits. Informed consent documentation signed and dated confirming that the patient has been adequately informed of all aspects related to his/her participation in the clinical study and is willing to participate. Exclusion Criteria: Bicuspid aortic valve anatomy Moderate to severe aortic valve regurgitation Multivalvular disease Redo Surgical Aortic Valve Replacement Ascending aorta aneurysm Aortic root enlargement Chronic Kidney Disease with estimated Glomerular Filtration Rate less than 30 milliliters per minute Body Mass Index greater than 30 kilograms per square meter Inadequate Multidetector Computed Tomography images
Where this trial is running
Cotignola, Ravenna
- Maria Cecilia Hospital — Cotignola, Ravenna, Italy (Recruiting)
Study contacts
- Principal investigator: Fausto Castriota — Maria Cecilia Hospital
- Study coordinator: Elena Tenti
- Email: etenti@gvmnet.it
- Phone: +39 0545217031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.