This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.
Study Type
OBSERVATIONAL
Enrollment
1,400
Integral Health
Adelaide, Australia
RECRUITINGRoyal Adelaide Hospital
Adelaide, Australia
COMPLETEDNemocnice Ceske Budejovice, a.s.
České Budějovice, Czechia
RECRUITINGHôpital Saint-André
Bordeaux, France
Time to diagnosis
Device is intended to detect rare arrhythmias. Time to detect this relevant arrhythmia will be recorded.
Time frame: The time to a relevant diagnosis can vary significantly. The time period starts with the insertion of the device.
Insertion procedure and success
Information on the insertion procedure (Operation time, handling of the BIOMONITOR incl. incision and insertion tool); Success rate of insertions.
Time frame: Data on BIOMONITOR insertion procedure and success rate are collected at day of insertion.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Le Centre Hospitalier Universitaire de Brest (CHRU Brest)
Brest, France
RECRUITINGLe Centre Hospitalier Universitaire de Caen (CHRU Caen)
Caen, France
RECRUITINGLe Centre Hospitalier Universitaire de Tours (CHRU Tours)
Chambray-lès-Tours, France
ACTIVE_NOT_RECRUITINGHôpital Gabriel Montpied
Clermont-Ferrand, France
RECRUITINGHôpital Haut Lévêque (CHU)
Pessac, France
RECRUITINGHôpitaux Universitaires de Strasbourg
Strasbourg, France
RECRUITING...and 21 more locations