BioMonitor Master Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01725568
First received: November 6, 2012
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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
ATRIAL FIBRILLATION, Syncope
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 ]

Estimated Enrollment: 142
Study Start Date: November 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 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

  Eligibility

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

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
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01725568     History of Changes
Other Study ID Numbers: 60
Study First Received: November 6, 2012
Last Updated: September 11, 2013
Health Authority: Slovakia: State Institute for Drug Control
Austria: Agency for Health and Food Safety

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

ClinicalTrials.gov processed this record on August 21, 2014