Trials / Completed
CompletedNCT01725568
BioMonitor Master Study
Master Study of the Implantable Cardiac Monitor "BioMonitor"
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 152 (actual)
- Sponsor
- Biotronik SE & Co. KG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BioMonitor | Implantable cardiac monitor |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2014-10-01
- Completion
- 2014-10-01
- First posted
- 2012-11-14
- Last updated
- 2014-11-20
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01725568. Inclusion in this directory is not an endorsement.