Atrial Fibrillation, Syncope, Tachyarrhythmia
Conditions
Brief summary
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.
Interventions
DEVICEBioMonitor 2
Implantation of BioMonitor 2
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2 | 3 month |
Secondary
| Measure | Time frame |
|---|---|
| R-Wave amplitude ≥ 0.3 mV | 1 week |
Outcome results
None listed