Bradycardia, Remote Monitoring
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPacemaker implantation
De novo implantation, device upgrade to dual chamber or device replacement
Sponsors
MicroPort CRM
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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) 2. Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker from MicroPort CRM 3. Patient implanted with any active or passive CE marked bipolar RA lead, and any active or passive CE marked bipolar RV lead 4. 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 5. Patient reviewed, signed and dated the ICF
Exclusion criteria
1. Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse width of 0.5 ms or below) 2. Patient with permanent AF 3. Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device) 4. 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) 5. Minor age patient (i.e. under 18 years of age) 6. Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation 7. Patient unavailable for the follow-up visits scheduled 8. Non-menopausal women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Right Atrial Autothreshold values at the inclusion and the M1-M3 visits | 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 | 1 to 3 months post-inclusion visit (M1-M3) |
| Technical remote alerts documented at the M1-M3 visit | 1 to 3 months post-inclusion visit (M1-M3) |
Secondary
| Measure | Time frame |
|---|---|
| Technical remote alerts documented up to the M48 visit | 48 months post-inclusion visit (M48) |
| Right Ventricular Autothreshold values up to the M48 visit | 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 | 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 | 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 | 48 months post-inclusion visit (M48) |
| Right Atrial Autothreshold values up to the M48 visit | 48 months post-inclusion visit (M48) |
| In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function up to the M48 visit | 48 months post-inclusion visit (M48) |
Countries
Austria, Belgium, France, Germany, Netherlands, Portugal, Spain, United Kingdom
Contacts
Primary ContactAntoine Guihard
Outcome results
None listed