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BioMonitor Master Study

NCT01725568 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2014-11-20

No results posted yet for this study

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

  • ATRIAL FIBRILLATION, Syncope

Interventions

DEVICE

BioMonitor

Implantable cardiac monitor

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Dietmar Baensch, Professor · University of Rostock, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01725568 on ClinicalTrials.gov