Clinical evaluation of a small implantable cardiac monitor with a long sensing vector.

ABSTRACT:

Introduction

We conducted this study to show the safety and efficacy of a new implantable cardiac monitor (ICM), the BioMonitor 2 (Biotronik SE & Co. KG; Berlin, Germany), and to describe the arrhythmia detection performance.

Methods

The BioMonitor 2 has an extended sensing vector and is implanted close to the heart. It can transmit up to six subcutaneous electrocardiogram strips by Home Monitoring each day. We enrolled 92 patients with a standard device indication for an ICM in a single-arm, multicenter prospective trial. Patients were followed for 3 months, and 48-h Holter recordings were used to evaluate the arrhythmia detection performance.

Results

One patient withdrew consent and in one patient, the implantation failed. Two study device-related serious adverse ev

SUBMITTER: Piorkowski C 

PROVIDER: S-EPMC6851891 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature