BioMonitor Master Study

Completed

• Conditions: ATRIAL FIBRILLATION, Syncope
• Interventions: Device: BioMonitor

• Registration Number: NCT01725568
• Lead Sponsor: Biotronik SE & Co. KG

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

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-14
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Implantable cardiac monitor diagnostics	BioMonitor	Patients has standard indication for implantable cardiac monitor diagnostic.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Rostock; 🇩🇪 Rostock, Germany