BIO.MASTER.BioMonitor 2 Study

Master Study of the Insertable Cardiac Monitor BioMonitor 2.

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Syncope; Tachyarrhythmia
• Intervention / Treatment: Device: BioMonitor 2

• Study Type: Observational
• Enrollment (Actual): 92

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patient collective consists mainly of patients with indications of an insertable cardiac monitor or who are planned for loop recorded guided AF-therapy management. The investigator will select patients who are appropriate for particiation from his general patient population.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2	3 month

Secondary Outcome Measures

Outcome Measure	Time Frame
R-Wave amplitude ≥ 0.3 mV	1 week

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Christopher Piorkowski, MD, Heart Center Dresden, Germany

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Unconsciousness; Consciousness Disorders; Atrial Fibrillation; Tachycardia; Syncope
• Other Study ID Numbers: BA105