BioMonitor Master Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Implantable cardiac monitor diagnostics Patients has standard indication for implantable cardiac monitor diagnostic. |
Device: BioMonitor
Implantable cardiac monitor
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Rostock | Rostock | Germany | 18057 |
Sponsors and Collaborators
- Biotronik SE & Co. KG
Investigators
- Principal Investigator: Dietmar Baensch, Professor, University of Rostock, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 60