BIO.MASTER.BioMonitor 2 Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Tachyarrhythmia Atrial Fibrillation Syncope

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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BioMonitor 2

Implantation of BioMonitor 2

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No