Physiologic Pacing Registry

The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of cardiac structures prior to physiologic pacing device implants based on the clinical site's routine care.

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Key information

Conditions

Bradycardia Arrhythmia, Sinus Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiomyopathies Cardiovascular Diseases Consciousness Disorders Heart Block Heart Diseases Heart Failure Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Sick Sinus Syndrome Signs and Symptoms Sinus Node Dysfunction Syncope Tachycardia Tachycardia, Ventricular Unconsciousness Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Northern Hospital, Epping, Victoria, Australia

About this study

The Physiologic Pacing Registry will be conducted to gain a deeper understanding of physiologic pacing device implants and follow-up workflows, including device and programmer measurements to help inform Abbott's product and clinical data development efforts. Additionally, the registry will provide a broader understanding of the clinical utility in mapping physiologic pacing structures with the use of Abbott's EnSite Cardiac Mapping System with an electrophysiology catheter prior to device implants for those institutions where mapping is routine care prior to physiologic pacing device implant.

The registry will include patients undergoing implantation of an Abbott pacemaker, defibrillator, or a cardiac resynchronization therapy (CRT) pacemaker (CRT-P) or CRT defibrillator (CRT-D) according to the clinical site's routine care. Only patients scheduled to receive an Abbott device may be enrolled to ensure proper device data collection for future software and other physiologic pacing product development. The decision to provide physiologic pacing therapy and selection of devices for implant are at the discretion of the implanting physician. Abbott will collect data on the use of all commercially available leads and associated implant tools based on the physician's discretion as part of routine clinical practice within the registry.

Who can participate

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

Inclusion criteria

Scheduled for implantation of an Abbott pacemaker, defibrillator, or CRT-P/D device with any commercially available pacing lead as part of a physiologic pacing procedure according to the clinical site's routine care.
At least 18 years of age.
Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Provided written informed consent prior to any registry-related procedures.

Exclusion criteria

History of tricuspid valve repair or replacement.
Currently participating in another clinical study with an active treatment arm and belong to the active arm
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the registry or to comply with follow-up requirements, or impact the scientific soundness of the registry results.
Chronic physiologic pacing lead implanted
Life expectancy of < 6 months.
Known contraindication for physiologic pacing therapy/implant (i.e. ongoing infection, known occlusion of the subclavian vein, etc.).

Treatment and study plan

Physiologic pacing device implant

Device

An alternative and potentially more effective pacing strategy for patients with electrical conduction abnormalities is physiologic pacing. Physiologic pacing is achieved by delivering a pacing stimulus to a cardiac conduction structure, such as the bundle of His or left bundle branch (LBB) of the His-Purkinje system, with a permanent lead. Physiologic pacing activates the heart through the native His-Purkinje conduction system, thus offering the most physiologic pacing approach to correct electrical dyssynchrony. Physiologic pacing has emerged as a feasible and safe alternative to pacemaker therapy and CRT with clinical and electrophysiological advantages.

Primary outcomes

Physiologic Pacing Implant Success Rate

Time frame: During procedure

849 subjects underwent attempted implants of physiologic pacing leads. Implant success rate was based on investigator-reported outcome.
Pacing Capture Threshold for His Bundle Pacing

Time frame: 6 Months

The pacing capture threshold was collected to characterize electrical performance in the Bundle of His area at 6 months. Pacing capture threshold is the minimum amount of voltage (V) needed to depolarize the myocardium or heart muscle with an electrical impulse from a pacemaker, ICD, or CRT.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Oct 25, 2018
Registry last updated: Aug 19, 2024

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.

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Completed