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Clinical Trials in the Netherlands / NCT06603454
Recruiting Not applicable

Preoperative Chest CT-imaging in Surgical Aortic Valve Replacement with or Without CABG

NCT06603454 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Romy Hegeman
Phase
Not applicable
Started
2023-12-04
Last updated
2024-09-19

Condition(s) studied

Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

Preoperative CT

Preoperative CT: Preoperative contrast enhanced CT

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
St. Antonius Hospital Nieuwegein Utrecht Recruiting

More Romy Hegeman trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06603454 on ClinicalTrials.gov ↗ ← All trials in the Netherlands