Paroxysmal and persistent atrial fibrillation
Conditions
Interventions
Implantation of the BioMonitor III ICM device.
Sponsors
Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AF detection performance metrics of the BioMonitor III ICM device compared to that of simultaneous Holter monitoring in patients before and after PVI. AF detection performance of the BioMonitor III ICM device will be expressed as sensitivity, specificity, positive predictive value and negative predictive value (both for episodes and duration). | — |
Secondary
| Measure | Time frame |
|---|---|
| ICM- or insertion-related complications at 6 months post-ICM insertion | — |
Contacts
Public ContactSing-Chien Yap
Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
Outcome results
None listed