NCT03564860

HBP Device EGM Data Collection

His Bundle Pacing Device Electrogram Data Collection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. Prospective data collection includes surface electrocardiograms, intracardiac electrograms, and pacing parameters, recorded during a patient visit. Additional retrospective data collection includes procedural data during the HB pacing lead and device implant. Up to 200 subjects will participate in this clinical investigation. The clinical investigation will be conducted at up to 8 centers worldwide. The total duration of the clinical investigation is expected to be 1 year, including enrollment and data collection from all subjects.

Conditions

• Sick Sinus Syndrome
• AV Block
• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Device data collection	Collection of device electrograms and 12-lead ECG during a device follow-up visit

Timeline

• Start date: 2018-07-17
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2018-06-21
• Last updated: 2020-10-08

Locations

3 sites across 1 country: United States