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Preoperative Chest CT-imaging in Surgical Aortic Valve Replacement with or Without CABG: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
St. Antonius Hospital
RECRUITING
Nieuwegein
Contact Information
Primary
Romy Hegeman, MD
r.hegeman@antoniusziekenhuis.nl
+31 (0)6 41 71 16 79
Backup
Simon van Putten, MD
s.van.putten@antoniusziekenhuis.nl
+31 (0)88 320 12 13
Time Frame
Start Date: 2023-12-04
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 380
Treatments
Active_comparator: Preoperative CT
Contrast-enhanced computed tomography of the aorta including the femoral arteries.
No_intervention: No preoperative CT
Sponsors
Leads: Romy Hegeman
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

This content was sourced from clinicaltrials.gov