BIO.MASTER.BioMonitor 2 Study

Biotronik

Status: Completed

Conditions: Syncope; Atrial Fibrillation; Tachyarrhythmia

Treatments: Device: BioMonitor 2

Study type: Observational

Funder types: Industry

Identifiers

NCT02565238

BA105

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.