HBP Device EGM Data Collection
His Bundle Pacing Device Electrogram Data Collection
1 other identifier
observational
200
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedStudy Start
First participant enrolled
July 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedOctober 8, 2020
October 1, 2020
2.2 years
May 15, 2018
October 5, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Amplitude of device electrogram
Mean amplitude of device electrogram during His bundle pacing
through study completion, an average of 1 year
Duration of device electrogram
Mean duration of device electrogram during His bundle pacing
through study completion, an average of 1 year
Study Arms (1)
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.
Interventions
Collection of device electrograms and 12-lead ECG during a device follow-up visit
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Suspected pacing system failure
- Lead impedance out of range
- Ventricular sensing amplitude lower than 0.5 mV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
*Heart Center Research, LLC.
Huntsville, Alabama, 35801, United States
Donald Guthrie Foundation for Education & Research
Sayre, Pennsylvania, 18840, United States
Greenville Health System
Greenville, South Carolina, 29605, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2018
First Posted
June 21, 2018
Study Start
July 17, 2018
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share