ATRIAL FIBRILLATION, Syncope Clinical Trial
— BioMonitorOfficial title:
Master Study of the Implantable Cardiac Monitor "BioMonitor"
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.
| Status | Completed |
| Enrollment | 152 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | University of Rostock | Rostock |
| Lead Sponsor | Collaborator |
|---|---|
| Biotronik SE & Co. KG |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Sensitivity and Positive Predictive of episode detection | 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) | 1 year | No |
| Other | Adverse events | 1 year | Yes | |
| Primary | SADE free-rate | SADE free-rate > 90% at 3 month follow-up | at 3 month follow-up | Yes |
| Primary | Rate of appropriate QRS detection | Rate of appropriate QRS detection > 90% (based on comparison with Holter ECG recording) | at 6 week follow-up | No |