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Clinical Trials/NL-OMON23516
NL-OMON23516
Not yet recruiting
Not Applicable

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

Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands0 sites30 target enrollmentStarted: TBDLast updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
Enrollment
30

Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational non invasive

Eligibility Criteria

Inclusion Criteria

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • 1\.Diagnosis of paroxysmal or persistent AF
  • 2\.Subject scheduled to undergo PVI within 6 months
  • 3\.Subject willing and able to comply with the follow\-up requirements of the study
  • 4\.Written informed consent obtained from subject aged 18 years or older

Exclusion Criteria

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • 1\.Diagnosis of long\-standing persistent AF
  • 2\.Subjects implanted with a previous ICM, pacemaker, implantable cardioverter defibrillator 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

Sponsor
Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands

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