HBP Device EGM Data Collection

His Bundle Pacing Device Electrogram Data Collection

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.

Inclusion Criteria:

• Has previously implanted with Abbott device and any pacing lead at HB
• Age ≥ 18 years
• Ability to provide informed consent for study participation
• Willing to comply with study evaluation requirements

Exclusion Criteria:

• Suspected pacing system failure
• Lead impedance out of range
• Ventricular sensing amplitude lower than 0.5 mV