Greenville, South Carolina 29605

  • Heart Failure

Purpose:

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.


Criteria:

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


NCT ID:

NCT03564860


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Greenville, South Carolina 29605
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 26, 2021

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