BioMonitor Master Study
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Master Study of the Implantable Cardiac Monitor "BioMonitor"|
- SADE free-rate [ Time Frame: at 3 month follow-up ] [ Designated as safety issue: Yes ]SADE free-rate > 90% at 3 month follow-up
- Rate of appropriate QRS detection [ Time Frame: at 6 week follow-up ] [ Designated as safety issue: No ]Rate of appropriate QRS detection > 90% (based on comparison with Holter ECG recording)
- Sensitivity and Positive Predictive of episode detection [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Implantable cardiac monitor diagnostics
Patients has standard indication for implantable cardiac monitor diagnostic.
Implantable cardiac monitor