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

NCT07125469 | Recruiting

• 1 other identifier: SAVR-CT-AVA
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to understand why there may be differences between the measurements of the aortic valve taken before and during surgery. Specifically, it will compare the valve size suggested by a CT scan (Computed Tomography) with the size measured during the operation using surgical tools. This will help determine which method is more accurate for selecting the right valve size in patients undergoing SAVR (Surgical Aortic Valve Replacement ).

Conditions

Valvular Heart Disease

Keywords

valve size, Surgical Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• Aortic Valve Annular sizing in Surgical Aortic Valve Replacement

  All patients with severe aortic stenosis (narrowing of the aortic valve) scheduled for Surgical Aortic Valve Replacement (SAVR), which is open-heart surgery to replace the valve with a bioprosthetic (tissue) valve, will have a pre-operative Computed Tomography (CT) scan. This CT scan follows the pre-Transcatheter Aortic Valve Replacement (pre-TAVR) protocol and focuses on the aortic root (the base of the aorta). It uses retrospective electrocardiogram (ECG) gating, a technique that times image capture with the heartbeat to get clear pictures of the heart.

  pre-operative

Study Arms (1)

Patients with severe AS and indication to SAVR with bioprosthetic valve

OTHER

Other: The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses

Interventions

The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses OTHER

All patients with severe aortic stenosis (AS) who are scheduled for Surgical Aortic Valve Replacement (SAVR) with a bioprosthetic valve will undergo a pre-operative Computed Tomography (CT) scan. This CT scan will follow the pre-Transcatheter Aortic Valve Replacement (pre-TAVR) protocol and will focus only on imaging the aortic root, using a method called retrospective electrocardiogram (ECG) gating to capture detailed heart motion. The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses:

Patients with severe AS and indication to SAVR with bioprosthetic valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Cecilia Hospital: lead

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Prostheses and Implants

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Fausto Castriota

  Maria Cecilia Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Tenti

CONTACT

+39 0545217031; etenti@gvmnet.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 15, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)