Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-28 @ 4:30 PM
Study NCT ID:
NCT01725568
Status:
COMPLETED
Last Update Posted:
2014-11-20
First Post:
2012-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BioMonitor Master Study
Sponsor:
Biotronik SE & Co. KG
Organization:
Study Overview
Official Title:
Master Study of the Implantable Cardiac Monitor "BioMonitor"
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BioMonitor
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: