Actively Recruiting
Preoperative Chest CT-imaging in Surgical Aortic Valve Replacement with or Without CABG
Led by Romy Hegeman · Updated on 2024-09-19
380
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
R
Romy Hegeman
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preoperative Chest CT-imaging in Surgical Aortic Valve Replacement with or Without CABG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary symptomatic severe aortic valve stenosis defined as an aortic valve area of less than 1.0 cm2 and either a mean valve gradient of at least 40 mmHg or a peak velocity of at least 4.0 m/s
- Accepted for surgical aortic valve replacement (SAVR) with or without concomitant coronary artery bypass grafting (CABG) by the Heart Team
- Planned SAVR approach may be limited access or conventional median sternotomy based on patient or surgeon preference
- Able to provide informed consent
You will not qualify if you...
- Previous aortic valve replacement
- Emergency procedure
- Pregnant women
- Renal failure with estimated glomerular filtration rate below 30 ml/min
- Known allergy to contrast agent
- Unwilling to be informed about unexpected findings on CT or MRI scans
- Contraindications to MRI including permanent pacemaker or ICD that cannot be inactivated, morphine or insulin pump, neurostimulator
- Declined or unable to provide informed consent
- Unable to understand the informed consent or study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435 CM
Actively Recruiting
Research Team
R
Romy Hegeman, MD
CONTACT
S
Simon van Putten, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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