Master Study of the Insertable Cardiac Monitor BioMonitor 2.

Biotronik SE & Co. KG0 sites92 target enrollmentSeptember 2015

ConditionsTachyarrhythmia Atrial Fibrillation Syncope

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tachyarrhythmia
Sponsor: Biotronik SE & Co. KG
Enrollment: 92
Primary Endpoint: Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

February 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Biotronik SE & Co. KG

Responsible Party

Sponsor

Eligibility Criteria

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.