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Clinical Trials/NL-OMON52211
NL-OMON52211
Recruiting
Phase 4

Comparing effectiveness and safety of Left Atrial Appendage Occlusion for non-valvular Atrial Fibrillation patients at high stroke risk unable to use oral anticoagulation therapy - COMPARE-LAAO

Sint Antonius Ziekenhuis0 sites609 target enrollmentTBD
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ConditionsAfibAtrial fibrillation10007521

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Afib
Sponsor
Sint Antonius Ziekenhuis
Enrollment
609
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

  • •1\. Documented non\-valvular AF (paroxysmal or non\-paroxysmal) and
  • •2\. CHA2DS2\-VASc score of 2 or more and
  • •3\. unsuitable for long\-term use of oral anticoagulation as determined by the
  • •referring physician team as well as the multidisciplinary team in the study
  • •hospital and
  • •4\. suitable for dual ATP for at least 3 mo and single APT from 3 until at most
  • •5\. At least 18 years of age, and willing and able to provide informed consent
  • •and adhere to study rules and regulations and follow\-up

Exclusion Criteria

  • •1\. any invasive cardiac procedure within 30 days prior to randomization and 90
  • •days after LAAO that would interfere with the study follow\-up and medication
  • •2\. unsuitable LAA anatomy for closure or thrombus in the LAA at the time of
  • •3\. contraindications or unfavourable conditions to perform cardiac
  • •catheterization or TEE
  • •4\. atrial septal malformations, atrial septal defect or a high\-risk patient
  • •foramen ovale that may cause thrombo\-embolic events
  • •5\. atrial septal defect repair or closure device or a patent foramen ovale
  • •repair or any other anatomical condition as this may preclude an LAAO procedure
  • •6\. LVEF\<31% and/or heart failure NYHA 3\-4

Outcomes

Primary Outcomes

Not specified

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