Preoperative Chest CT-imaging in Surgical Aortic Valve Replacement with or Without CABG
Recruiting now · Not applicable
Conditions studied: Aortic Valve Stenosis
In brief
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 is not yet part of routine clinical practice in SAVR patients. The researchers hypothesise that when atherosclerosis of the ascending aorta is identified preoperatively on contrast-enhanced multi-slice computed tomography (MSCT), the subclinical perioperative stroke rate (as detected on diffusion-weighted magnetic resonance imaging (DW-MRI)) can be reduced by modification of the operative strategy if necessary.
Key facts
- Study ID
- NCT06603454
- Run by
- Romy Hegeman
- People needed
- 380
- Starts
- 2023-12-04
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- St. Antonius Hospital — Nieuwegein, Utrecht, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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