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BioMonitor Master Study

NCT ID: NCT01725568

Last Updated: 2014-11-20

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

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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ATRIAL FIBRILLATION, Syncope

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Implantable cardiac monitor diagnostics

Patients has standard indication for implantable cardiac monitor diagnostic.

BioMonitor

Intervention Type DEVICE

Implantable cardiac monitor

Interventions

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BioMonitor

Implantable cardiac monitor

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotronik SE & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dietmar Baensch, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Rostock, Germany

Locations

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University of Rostock

Rostock, , Germany

Site Status

Countries

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Germany

Other Identifiers

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60

Identifier Type: -

Identifier Source: org_study_id