Physiologic Pacing Registry

N/ACompletedNCT03719040

Abbott Medical Devices870 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

870

Conditions

Bradycardia Sinus Node Dysfunction

Interventions

Physiologic pacing device implantDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. At least 18 years of age. 3. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations. 4. Provided written informed consent prior to any registry-related procedures. Exclusion Criteria: 1. History of tricuspid valve repair or replacement. 2. Currently participating in another clinical study with an active treatment arm and belong to the active arm 3. 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. 4. Chronic physiologic pacing lead implanted 5. Life expectancy of \< 6 months. 6. Known contraindication for physiologic pacing therapy/implant (i.e. ongoing infection, known occlusion of the subclavian vein, etc.).

Locations (50)

Heart Center Research, LLC.

Huntsville, Alabama, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

University of California at San Diego (UCSD) Medical Center

San Diego, California, United States

Yoel R. Vivas, MD

Delray Beach, Florida, United States

Usman R. Siddiqui, MD

Winter Park, Florida, United States

Outcomes

Primary Outcomes

Physiologic Pacing Implant Success Rate

849 subjects underwent attempted implants of physiologic pacing leads. Implant success rate was based on investigator-reported outcome.

Time frame: During procedure

Pacing Capture Threshold for His Bundle Pacing

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.

Time frame: 6 Months