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BioMonitor Master Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01725568
First received: November 6, 2012
Last updated: November 19, 2014
Last verified: November 2014

November 6, 2012
November 19, 2014
November 2012
October 2014   (final data collection date for primary outcome measure)
  • 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)
Same as current
Complete list of historical versions of study NCT01725568 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • 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 ]
Same as current
 
BioMonitor Master Study
Master Study of the Implantable Cardiac Monitor "BioMonitor"

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with standard ICM indication who are referred to the hospital

ATRIAL FIBRILLATION, Syncope
Device: BioMonitor
Implantable cardiac monitor
Implantable cardiac monitor diagnostics
Patients has standard indication for implantable cardiac monitor diagnostic.
Intervention: Device: BioMonitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01725568
60
No
Biotronik SE & Co. KG
Biotronik SE & Co. KG
Not Provided
Principal Investigator: Dietmar Baensch, Professor University of Rostock, Germany
Biotronik SE & Co. KG
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP