Physiologic Pacing Registry

Completed

Conditions: Heart Block
Syncope
Heart Failure
Bradycardia
Sinus Node Dysfunction
Cardiomyopathies
Ventricular Tachycardia

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.).

Primary Outcome Measures

Name	Time	Method
Pacing Capture Threshold for His Bundle Pacing	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.
Physiologic Pacing Implant Success Rate	During procedure	849 subjects underwent attempted implants of physiologic pacing leads. Implant success rate was based on investigator-reported outcome.

Secondary Outcome Measures

Name	Time	Method

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
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
University of Chicago
🇺🇸
Chicago, Illinois, United States
IU Health Bloomington Hospital
🇺🇸
Bloomington, Indiana, United States
Iowa Heart Center
🇺🇸
West Des Moines, Iowa, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
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Heart Center Research, LLC.
🇺🇸Huntsville, Alabama, United States