NCT05165095 Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
| NCT ID | NCT05165095 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MicroPort CRM |
| Condition | Bradycardia |
| Study Type | OBSERVATIONAL |
| Enrollment | 206 participants |
| Start Date | 2022-03-25 |
| Primary Completion | 2023-09-05 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
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 contr