An observational study in Bradycardia and Remote Monitoring, sponsored by MicroPort CRM. Recruiting at 19 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by MicroPort CRM (part of MicroPort Scientific Corporation) · Observational
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.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's planned enrollment of 206 is below the median of 257 across 127 observational studies indexed under Bradycardia.
Browse Bradycardia studies →MicroPort CRM is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
First submitted after MicroPort CRM became part of MicroPort Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
Patients indicated (class I or II) for a dual chamber pacemaker (de novo implantation, device upgrade to dual chamber or device replacement), according to the most recent guidelines from the ESC.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
De novo implantation, device upgrade to dual chamber or device replacement
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)
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)
Plan to share: No
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