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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaria Cecilia Hospital

About this trial

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 ).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 intervention

    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:

Treatment groups

82 Participants
are divided into 1 treatment group
Group A: Patients with severe AS and indication to SAVR with bioprosthetic valveOther 1 intervention

Trial outcomes

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.

Time frame
pre-operative

Secondary outcomes

Other outcomes

Sponsors and contacts

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