BioMonitor Master Study (BioMonitor)

This study has been completed.
Information provided by (Responsible Party):
Biotronik SE & Co. KG Identifier:
First received: November 6, 2012
Last updated: November 19, 2014
Last verified: November 2014
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.

Condition Intervention
Device: BioMonitor

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Master Study of the Implantable Cardiac Monitor "BioMonitor"

Resource links provided by NLM:

Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • SADE free-rate [ Time Frame: at 3 month follow-up ] [ Designated as safety issue: Yes ]
    SADE free-rate > 90% at 3 month follow-up

  • Rate of appropriate QRS detection [ Time Frame: at 6 week follow-up ] [ Designated as safety issue: No ]
    Rate of appropriate QRS detection > 90% (based on comparison with Holter ECG recording)

Other Outcome Measures:
  • Sensitivity and Positive Predictive of episode detection [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Sensitivity and Positive Predictive Value of each automatically detected cardiac arrhythmia that was stored as subcutaneous electrocardiogram by the BioMonitor (6 week, 3 and 12 month follow-up data)

  • Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 152
Study Start Date: November 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Implantable cardiac monitor diagnostics
Patients has standard indication for implantable cardiac monitor diagnostic.
Device: BioMonitor
Implantable cardiac monitor


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with standard ICM indication who are referred to the hospital

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01725568

University of Rostock
Rostock, Germany, 18057
Sponsors and Collaborators
Biotronik SE & Co. KG
Principal Investigator: Dietmar Baensch, Professor University of Rostock, Germany
  More Information

Responsible Party: Biotronik SE & Co. KG Identifier: NCT01725568     History of Changes
Other Study ID Numbers: 60 
Study First Received: November 6, 2012
Last Updated: November 19, 2014
Health Authority: Slovakia: State Institute for Drug Control
Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on May 26, 2016