BioMonitor Master Study

Biotronik SE & Co. KG152 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

152

Conditions

ATRIAL FIBRILLATION, Syncope

Interventions

BioMonitorDEVICE

Implantable cardiac monitor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Rostock

Rostock, Germany

Outcomes

Primary Outcomes

SADE free-rate

SADE free-rate \> 90% at 3 month follow-up

Time frame: at 3 month follow-up

Rate of appropriate QRS detection

Rate of appropriate QRS detection \> 90% (based on comparison with Holter ECG recording)

Time frame: at 6 week follow-up

Data from ClinicalTrials.gov

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