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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
*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
Start Date
July 17, 2018
Primary Completion Date
September 30, 2020
Completion Date
September 30, 2020
Last Updated
October 8, 2020
200
ACTUAL participants
Device data collection
PROCEDURE
Lead Sponsor
Abbott Medical Devices
NCT07484009
NCT07191730
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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