The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.
All patients will be included just after implantation and will then be followed during 48 months after inclusion. At each on-site or remote follow-up visit (1 to 3 months, 6, 12, 24 and 48 months), performances of the remote monitoring functions and the cardiac pacing system itself will be measured, and safety will be monitored during the whole clinical investigation duration.
Study Type
OBSERVATIONAL
Enrollment
206
De novo implantation, device upgrade to dual chamber or device replacement
Universitätsklinikum Krems
Krems, Austria
RECRUITINGAllgemeines Krankenhaus Wien
Vienna, Austria
Right Atrial Autothreshold values at the inclusion and the M1-M3 visits
Time frame: 1 to 3 months post-inclusion visit (M1-M3)
In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function at the inclusion and the M1-M3 visits
Time frame: 1 to 3 months post-inclusion visit (M1-M3)
Technical remote alerts documented at the M1-M3 visit
Time frame: 1 to 3 months post-inclusion visit (M1-M3)
Right Atrial Autothreshold values up to the M48 visit
Time frame: 48 months post-inclusion visit (M48)
In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function up to the M48 visit
Time frame: 48 months post-inclusion visit (M48)
Technical remote alerts documented up to the M48 visit
Time frame: 48 months post-inclusion visit (M48)
Right Ventricular Autothreshold values up to the M48 visit
Time frame: 48 months post-inclusion visit (M48)
Safety of ALIZEA, BOREA and CELEA pacemaker and of SMARTVIEW CONNECT remote monitoring systems up to the M48 visit
Time frame: 48 months post-inclusion visit (M48)
Electrical performances (pacing thresholds, impedance & minimum sensed amplitude) of ALIZEA, BOREA and CELEA pacemaker systems up to the M48 visit
Time frame: 48 months post-inclusion visit (M48)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinique Saint Joseph
Arlon, Belgium
RECRUITINGCHU Bordeaux
Bordeaux, France
RECRUITINGCH Chartres
Le Coudray, France
RECRUITINGCHU Hôpital de la Timone
Marseille, France
RECRUITINGCHU Nantes
Nantes, France
RECRUITINGClinique Pasteur Toulouse
Toulouse, France
RECRUITINGCH Valence
Valence, France
RECRUITINGCardiologicum Hamburg
Hamburg, Germany
RECRUITING...and 9 more locations
Usability of ALIZEA, BOREA and CELEA pacemaker and of SMARTVIEW CONNECT remote monitoring systems up to the M48 visit
Time frame: 48 months post-inclusion visit (M48)