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OpenTrials
Completed

NCT Number: NCT01725568

BioMonitor Master Study

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.

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Key information

Conditions

ATRIAL FIBRILLATION, Syncope Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Consciousness Disorders Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Syncope Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rostock

Rostock, 18057, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BioMonitor

Device

Implantable cardiac monitor

Primary outcomes

  1. SADE free-rate

    Time frame: at 3 month follow-up

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

  2. 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)

Other outcomes

  1. Sensitivity and Positive Predictive of episode detection

    Time frame: 1 year

    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)

  2. Adverse events

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Master Study of the Implantable Cardiac Monitor "BioMonitor"

Acronym: BioMonitor

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 14, 2012
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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