AV Block, Heart Failure, Sick Sinus Syndrome
Conditions
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.
Interventions
PROCEDUREDevice data collection
Collection of device electrograms and 12-lead ECG during a device follow-up visit
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amplitude of device electrogram | through study completion, an average of 1 year | Mean amplitude of device electrogram during His bundle pacing |
| Duration of device electrogram | through study completion, an average of 1 year | Mean duration of device electrogram during His bundle pacing |
Countries
United States
Outcome results
None listed