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.
Study Type
OBSERVATIONAL
Enrollment
200
Collection of device electrograms and 12-lead ECG during a device follow-up visit
*Heart Center Research, LLC.
Huntsville, Alabama, United States
Donald Guthrie Foundation for Education & Research
Sayre, Pennsylvania, United States
Greenville Health System
Greenville, South Carolina, United States
Amplitude of device electrogram
Mean amplitude of device electrogram during His bundle pacing
Time frame: through study completion, an average of 1 year
Duration of device electrogram
Mean duration of device electrogram during His bundle pacing
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.