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Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

Study acronym: CALLIOPE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date changed from estimate of Jul 2023 to Sep 5, 2023v6
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Minor Study sites: 17 to 19
    • Primary completion date: Jan 2023 to Jul 2023
    • Study completion date: Dec 2026 to Jul 2027
    v4
  4. Minor Study sites: 4 to 17v3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Mar 2022 to Mar 25, 2022
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05165095
Lead Sponsor MicroPort CRM
Conditions
(from sponsor)
Bradycardia, Remote Monitoring
Related terms Bradycardia
Enrollment 206 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov