Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
NCT05165095 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 206
Last updated 2024-05-31
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.
Conditions
- Bradycardia
- Remote Monitoring
Interventions
- DEVICE
-
Pacemaker implantation
De novo implantation, device upgrade to dual chamber or device replacement
Sponsors & Collaborators
-
MicroPort CRM
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-25
- Primary Completion
- 2023-09-05
- Completion
- 2027-07-31
Countries
- Austria
- Belgium
- France
- Germany
- Netherlands
- Portugal
- Spain
- United Kingdom
Study Locations
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