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OpenTrials
Completed

NCT Number: NCT02565238

BIO.MASTER.BioMonitor 2 Study

The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is collected to support the regulatory approval of this product in countries outside the CE region.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients without history of atrial fibrillation and with an indication for BioMonitor 2 device or paients planned for loop recorded guided AF-therapy management, with either current known and documented paroxysmal atrial fibrillation or with current known and documented persistent atrial fibrillation indicated for an ablation or was ablated within the last four weeks.
  • Patient is able to understand the nature of the study and provides written informed consent.
  • Patient is able and willing to complete the planned follow-up visits at the investigational site.
  • Patient accepts the Home Monitoring® concept.
  • Age is ≥ 18 years.

Exclusion criteria

  • Patients implanted with ICD or pacemaker.
  • Patient who is pregnant and/or breast-feeding or who intends to become pregnant during the time of the study will be excluded.
  • Life expectancy of less than 6 months.
  • Participation in another interventional clinical investigation. Participation in a non-interventional study is permitted.

Treatment and study plan

BioMonitor 2

Device

Implantation of BioMonitor 2

Primary outcomes

  1. Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2

    Time frame: 3 month

Secondary outcomes

  1. R-Wave amplitude ≥ 0.3 mV

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Master Study of the Insertable Cardiac Monitor BioMonitor 2.

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 1, 2015
Registry last updated
May 8, 2017

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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