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Clinical Trials/NL-OMON48234
NL-OMON48234
Completed
Not Applicable

BioMonitor III: Validation of the Atrial fibrillation Detecting algorithm in patients undergoing pulmonary vein isolation - BioVAD study

Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites30 target enrollmentStarted: TBDLast updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
30

Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational invasive

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • 1\. Diagnosis of paroxysmal or persistent AF as defined by the 2016 ESC
  • guidelines for the management of atrial fibrillation
  • 2\. Subject scheduled to undergo PVI within 6 months
  • 3\. Subject willing and able to comply with the follow\-up requirements of the
  • 4\. Written informed consent obtained from subject aged 18 years or older

Exclusion Criteria

  • 1\. Diagnosis of long\-standing persistent AF as defined by the 2016 ESC
  • guidelines for the management of atrial fibrillation
  • 2\. Subjects implanted with a previous ICM, pacemaker, ICD, or cardiac
  • resynchronization therapy device
  • 3\. Subjects with an active infection
  • 4\. Subjects enrolled in another clinical study which may confound the results
  • of this study
  • 5\. Subjects with a life expectancy of \<1 year due to any condition

Investigators

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