Status:
RECRUITING
Preoperative Chest CT-imaging in Surgical Aortic Valve Replacement with or Without CABG
Lead Sponsor:
Romy Hegeman
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rationale When determining the strategy for aortic valve replacement, echocardiography is still considered the golden standard (1). While pre-procedural MSCT is standard of care in TAVR patients, this...
Detailed Description
When determining the strategy for aortic valve replacement, echocardiography is still considered the golden standard (1). While pre-procedural MSCT is standard of care in TAVR patients, this is not ye...
Eligibility Criteria
Inclusion
- Primary symptomatic severe aortic valve stenosis (defined as an aortic valve area of \<1.0cm2 and either a mean valve gradient of at least 40mmHg or a peak velocity of at least 4.0 m/s)
- Accepted for SAVR (either planned to be done by a limited access approach (partial J-shaped sternotomy or right anterior thoracotomy or conventional median sternotomy approach at the preference of the patient and/or the discretion of the surgeon) with or without concomitant CABG by the Heart Team
- Informed consent
Exclusion
- Previous aortic valve replacement
- Emergency procedure
- Pregnant women
- Renal failure (eGFR \<30 ml/min.)
- Known contrast allergy
- Patient unwilling to be informed about unrequested findings on the CT scan or DW-MRI scan
- Contra-indication for MRI (e.g. permanent pacemaker or ICD that can not be inactivated per order of the pacemaker or ICD technician, morphine or insulin pump, neurostimulator). All patients will fill out a MRI checklist to additionally check for (new) safety contra-indications for MRI.
- Patient who did not agree to the informed consent and/or refused to participate
- Patient unable to understand the informed consent/study
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT06603454
Start Date
December 4 2023
End Date
December 1 2025
Last Update
September 19 2024
Active Locations (1)
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1
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435 CM