Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2018-07-17
2020-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Device data collection
Collection of device electrograms and 12-lead ECG during a device follow-up visit
Interventions
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Device data collection
Collection of device electrograms and 12-lead ECG during a device follow-up visit
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Ability to provide informed consent for study participation
* Willing to comply with study evaluation requirements
Exclusion Criteria
* Lead impedance out of range
* Ventricular sensing amplitude lower than 0.5 mV
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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*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
Countries
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Other Identifiers
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ABT-CIP-10234
Identifier Type: -
Identifier Source: org_study_id
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