HBP Device EGM Data Collection

Completed

• Conditions: Heart Failure; Sick Sinus Syndrome; AV Block
• Interventions: Procedure: Device data collection

• Registration Number: NCT03564860
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-21
• Study Start: 2018-07-17
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HBP device data collection group	Device data collection	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.

Primary Outcome Measures

Name	Time	Method
Duration of device electrogram	through study completion, an average of 1 year	Mean duration of device electrogram during His bundle pacing
Amplitude of device electrogram	through study completion, an average of 1 year	Mean amplitude of device electrogram during His bundle pacing

Trial Locations

Locations (3)

*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