His Bundle Pacing Device Electrogram Data Collection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- Duration of device electrogram
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Duration of device electrogram
Time Frame: through study completion, an average of 1 year
Mean duration of device electrogram during His bundle pacing
Amplitude of device electrogram
Time Frame: through study completion, an average of 1 year
Mean amplitude of device electrogram during His bundle pacing
Secondary Outcomes
No secondary outcomes reported