Intraoperative Assessment Versus Preoperative Multidetector Computed Tomography (MDCT) for Aortic Valve Annular Sizing in Surgical Aortic Valve Replacement (SAVR)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 ).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Maria Cecilia Hospital
RECRUITING
Cotignola
Contact Information
Primary
Elena Tenti
etenti@gvmnet.it
+39 0545217031
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 82
Treatments
Other: Patients with severe AS and indication to SAVR with bioprosthetic valve
Sponsors
Leads: Maria Cecilia Hospital

This content was sourced from clinicaltrials.gov