Status:
RECRUITING
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
Lead Sponsor:
MicroPort CRM
Conditions:
Bradycardia
Remote Monitoring
Eligibility:
All Genders
18+ years
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 r...
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), p...
Eligibility Criteria
Inclusion Criteria:
- 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
- Patient reviewed, signed and dated the ICF
Exclusion Criteria:
- 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)
- Minor age patient (i.e. under 18 years of age)
- Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
- Patient unavailable for the follow-up visits scheduled
- Non-menopausal women
Key Trial Info
Start Date :
March 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT05165095
Start Date
March 25 2022
End Date
July 1 2027
Last Update
May 31 2024
Active Locations (19)
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1
Universitätsklinikum Krems
Krems, Austria
2
Allgemeines Krankenhaus Wien
Vienna, Austria
3
Clinique Saint Joseph
Arlon, Belgium
4
CHU Bordeaux
Bordeaux, France