Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMicroPort CRM
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient implanted according to the most recent guidelines from the ESC, for 20 days or less (de novo implantation, device upgrade to dual chamber or device replacement)
Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker from MicroPort CRM
Patient implanted with any active or passive CE marked bipolar RA lead, and any active or passive CE marked bipolar RV lead
Patient's pacemaker with the remote monitoring functions (i.e. the RAAT, the RVAT and the remote alerts) accepted by the patient and planned to be activated
Disqualifiers
Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse width of 0.5 ms or below)
Patient with permanent AF
Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pacemaker implantation
DeviceDe novo implantation, device upgrade to dual chamber or device replacement
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Right Atrial Autothreshold values at the inclusion and the M1-M3 visits
Time frame
1 to 3 months post-inclusion visit (M1-M3)2
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)3
Technical remote alerts documented at the M1-M3 visit
Time frame
1 to 3 months post-inclusion visit (M1-M3)Secondary outcomes
1
Right Atrial Autothreshold values up to the M48 visit
Time frame
48 months post-inclusion visit (M48)2
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)3
Technical remote alerts documented up to the M48 visit
Time frame
48 months post-inclusion visit (M48)4
Right Ventricular Autothreshold values up to the M48 visit
Time frame
48 months post-inclusion visit (M48)Sponsors and contacts
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Source ClinicalTrials.gov