Preoperative chest CT-imaging in surgical aortic valve replacement with or without CABG: a randomized controlled trial.

Recruiting

• Conditions: aortic valve stenosis; 10046973

• Registration Number: NL-OMON56045
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 380

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
- Patient unwilling to be informed about unrequested findings on the CT-scan or
MRI-scan
- Contra-indication for MRI
- Patient who did not agree to the informed consent and/or refused to
participate
- Patient unable to understand the informed consent/study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Subclinical stroke rate (i.e., presence of new ischemic brain lesions) as<br /><br>identified with the use of DW-MRI made within one week postoperatively or<br /><br>before discharge</p><br>