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Clinical Trials/NCT01725568
NCT01725568CompletedNot Applicable

Master Study of the Implantable Cardiac Monitor "BioMonitor"

Biotronik SE & Co. KG1 site in 1 country152 target enrollmentStarted: November 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
152
Locations
1
Primary Endpoint
SADE free-rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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