HBP Device EGM Data Collection
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|ClinicalTrials.gov Identifier: NCT03564860|
Recruitment Status : Completed
First Posted : June 21, 2018
Last Update Posted : October 8, 2020
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.
|Condition or disease||Intervention/treatment|
|Sick Sinus Syndrome AV Block Heart Failure||Procedure: Device data collection|
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||His Bundle Pacing Device Electrogram Data Collection|
|Actual Study Start Date :||July 17, 2018|
|Actual Primary Completion Date :||September 30, 2020|
|Actual Study Completion Date :||September 30, 2020|
HBP device data collection group
Device electrograms and 12-lead ECG will be collected from patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device during a standard-of-care device follow-up visit.
Procedure: Device data collection
Collection of device electrograms and 12-lead ECG during a device follow-up visit
- Amplitude of device electrogram [ Time Frame: through study completion, an average of 1 year ]Mean amplitude of device electrogram during His bundle pacing
- Duration of device electrogram [ Time Frame: through study completion, an average of 1 year ]Mean duration of device electrogram during His bundle pacing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564860
|United States, Alabama|
|*Heart Center Research, LLC.|
|Huntsville, Alabama, United States, 35801|
|United States, Pennsylvania|
|Donald Guthrie Foundation for Education & Research|
|Sayre, Pennsylvania, United States, 18840|
|United States, South Carolina|
|Greenville Health System|
|Greenville, South Carolina, United States, 29605|