- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03564860
HBP Device EGM Data Collection
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Alabama
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Huntsville, Alabama, United States, 35801
- *Heart Center Research, LLC.
-
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Pennsylvania
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Sayre, Pennsylvania, United States, 18840
- Donald Guthrie Foundation for Education & Research
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South Carolina
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Greenville, South Carolina, United States, 29605
- Greenville Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Collection of device electrograms and 12-lead ECG during a device follow-up visit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amplitude of device electrogram
Time Frame: through study completion, an average of 1 year
|
Mean amplitude of device electrogram during His bundle pacing
|
through study completion, an average of 1 year
|
Duration of device electrogram
Time Frame: through study completion, an average of 1 year
|
Mean duration of device electrogram during His bundle pacing
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABT-CIP-10234
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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