Comparing Measurements of the Aortic Valve Taken During Surgery With Those Obtained Before Surgery Using Computed Tomography Scans, in Patients Undergoing Surgical Aortic Valve Replacement

Launched by MARIA CECILIA HOSPITAL · Aug 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how measurements of the aortic valve—the valve between the heart and the body’s main artery—compare when taken before surgery using a special type of X-ray called a CT scan, versus measurements taken during the actual heart surgery. The goal is to find out which method gives the most accurate size of the valve, helping doctors choose the best replacement valve for patients who need surgical aortic valve replacement (SAVR) due to severe narrowing of the valve (called aortic stenosis).

Adults aged 18 and older who have severe aortic stenosis and are scheduled for this type of valve surgery may be eligible to join, as long as they don’t have other heart valve problems or certain health conditions like kidney disease or very large body weight. Participants will undergo the usual scans and surgery, and the study team will compare the valve sizes from the CT scan and the measurements taken during surgery. Patients will also be asked to come back for follow-up visits to help researchers better understand the differences in measurements. This study is currently looking for volunteers and aims to improve how doctors plan valve replacement surgeries in the future.

Gender

ALL

Eligibility 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