Aortic valve sizing: comparing CT scan measurements with measurements taken during surgery for people having surgical aortic valve replacement

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.