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HBP Device EGM Data Collection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03564860
Recruitment Status : Completed
First Posted : June 21, 2018
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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.
Procedure: Device data collection
Collection of device electrograms and 12-lead ECG during a device follow-up visit




Primary Outcome Measures :
  1. Amplitude of device electrogram [ Time Frame: through study completion, an average of 1 year ]
    Mean amplitude of device electrogram during His bundle pacing

  2. Duration of device electrogram [ Time Frame: through study completion, an average of 1 year ]
    Mean duration of device electrogram during His bundle pacing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The intended population for this clinical investigation consists of 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.
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Abbott Medical Devices
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03564860    
Other Study ID Numbers: ABT-CIP-10234
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sick Sinus Syndrome
Heart Diseases
Cardiovascular Diseases
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Block
Cardiac Conduction System Disease
Pathologic Processes