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Clinical Trials/NCT01725568
NCT01725568
Completed
Not Applicable

Master Study of the Implantable Cardiac Monitor "BioMonitor"

Biotronik SE & Co. KG1 site in 1 country152 target enrollmentNovember 2012
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ConditionsATRIAL FIBRILLATION, Syncope

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ATRIAL FIBRILLATION, Syncope
Sponsor
Biotronik SE & Co. KG
Enrollment
152
Locations
1
Primary Endpoint
SADE free-rate
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
October 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

SADE free-rate

Time Frame: at 3 month follow-up

SADE free-rate \> 90% at 3 month follow-up

Rate of appropriate QRS detection

Time Frame: at 6 week follow-up

Rate of appropriate QRS detection \> 90% (based on comparison with Holter ECG recording)

Study Sites (1)

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