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Clinical Trials/NL-OMON56045
NL-OMON56045
Recruiting
Not Applicable

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

Sint Antonius Ziekenhuis0 sites380 target enrollmentTBD
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Conditionsaortic valve stenosis10046973

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
aortic valve stenosis
Sponsor
Sint Antonius Ziekenhuis
Enrollment
380
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

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
  • •\- 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

Outcomes

Primary Outcomes

Not specified

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