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 Type
OBSERVATIONAL
Enrollment
92
Implantation of BioMonitor 2
Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2
Time frame: 3 month
R-Wave amplitude ≥ 0.3 mV
Time frame: 1 week
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