Trials / Recruiting
RecruitingNCT05165095
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 206 (estimated)
- Sponsor
- MicroPort CRM · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pacemaker implantation | De novo implantation, device upgrade to dual chamber or device replacement |
Timeline
- Start date
- 2022-03-25
- Primary completion
- 2023-09-05
- Completion
- 2027-07-01
- First posted
- 2021-12-21
- Last updated
- 2024-05-31
Locations
19 sites across 8 countries: Austria, Belgium, France, Germany, Netherlands, Portugal, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT05165095. Inclusion in this directory is not an endorsement.