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Studies

Interventional Completed

NCT07254013 on ClinicalTrials.gov

Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution

  • Sponsor: MicroPort (China)
  • Enrollment: 55 (Actual)
  • Study start: 2025-11-14 (Actual)
  • Primary completion: 2026-04-21 (Actual)
  • Study completion: 2026-06-12 (Actual)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

To evaluate the capability to monitor LBB success criteria with the use of a Smart ECG system (ECG monitor, 12 leads ECG cable, ECG viewer software ) during a cardiac device implantation involving the placement of a pacing lead in interventricular septum area

Conditions

  • Bradycardia
  • Left Bundle Branch Area Pacing
  • Cardiac Resynchronisation Therapy (CRT)
  • ECG

Intervention / Treatment

  • Device: LBBAP implant

Primary Outcome Measures

  • Capability to monitor LBB success criteria with the use of Smart ECG system (baseline/ procedure)
    Proportion of investigators providing an overall favorable assessment (assessed "GOOD or ACCEPTABLE") on a four- point scale (GOOD, ACCEPTABLE, POOR, VERY POOR) on the use of Smart ECG system to achieve LBB area pacing.

Countries

France

Locations and Investigators

  • CHU de Besançon, Besançon, France
  • Clermont Ferrand, Clermont-Ferrand, France
  • CHU Grenoble Alpes, Grenoble, France
  • Clinique du Millénaire, Montpellier, France

Study Officials