Skip to main content
OpenTrials
Completed

NCT Number: NCT03564860

HBP Device EGM 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sick Sinus Syndrome AV Block Arrhythmia, Sinus Arrhythmias, Cardiac Atrioventricular Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

*Heart Center Research, LLC., Huntsville, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device data collection

Procedure

Collection of device electrograms and 12-lead ECG during a device follow-up visit

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

His Bundle Pacing Device Electrogram Data Collection

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2018
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.