BioMonitor Master Study

Biotronik

Status: Completed

Conditions: ATRIAL FIBRILLATION, Syncope

Treatments: Device: BioMonitor

Study type: Observational

Funder types: Industry

Identifiers

NCT01725568

60

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

152 participants in 1 patient group

Implantable cardiac monitor diagnostics

Description:

Patients has standard indication for implantable cardiac monitor diagnostic.

Treatment:

Device: BioMonitor