BIO.MASTER.BioMonitor 2 Study

May 5, 2017 updated by: Biotronik SE & Co. KG

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

Intervention / Treatment

Device: BioMonitor 2

Study Type

Observational

Enrollment (Actual)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Investigators

Principal Investigator: Christopher Piorkowski, MD, Heart Center Dresden, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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