ATRIAL FIBRILLATION, Syncope
Conditions
Brief summary
The BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation. The study will be conducted to support regulatory approvals outside of Europe. This BioMonitor Master study is designed to investigate the clinical efficacy and safety of the BioMonitor.
Interventions
DEVICEBioMonitor
Implantable cardiac monitor
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Suspected cardiac arrhythmia OR Previous AF diagnosis OR AF diagnosis before or after ablation procedure OR Stroke of unknown origin.
Exclusion criteria
* Implanted ICD or cardiac pacemaker * Allergy to patch electrodes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SADE free-rate | at 3 month follow-up | SADE free-rate \> 90% at 3 month follow-up |
| Rate of appropriate QRS detection | at 6 week follow-up | Rate of appropriate QRS detection \> 90% (based on comparison with Holter ECG recording) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Positive Predictive of episode detection | 1 year | Sensitivity and Positive Predictive Value of each automatically detected cardiac arrhythmia that was stored as subcutaneous electrocardiogram by the BioMonitor (6 week, 3 and 12 month follow-up data) |
| Adverse events | 1 year | — |
Countries
Germany
Outcome results
None listed