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BioMonitor Master Study (BioMonitor)

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ClinicalTrials.gov Identifier: NCT01725568
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

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.

Condition or disease Intervention/treatment
ATRIAL FIBRILLATION, Syncope Device: BioMonitor

Study Type : Observational
Actual Enrollment : 152 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Master Study of the Implantable Cardiac Monitor "BioMonitor"
Study Start Date : November 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Implantable cardiac monitor diagnostics
Patients has standard indication for implantable cardiac monitor diagnostic.
Device: BioMonitor
Implantable cardiac monitor




Primary Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with standard ICM indication who are referred to the hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725568


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

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01725568     History of Changes
Other Study ID Numbers: 60
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Atrial Fibrillation
Syncope
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms