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
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Completed
Not Applicable
BioMonitor III: Validation of the Atrial fibrillation Detecting algorithm in patients undergoing pulmonary vein isolatioAtrial fibrillationirregular heart rhythm10007521NL-OMON48234Erasmus MC, Universitair Medisch Centrum Rotterdam30
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