Physiologic Pacing Registry

Completed

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

Registration Number: NCT03719040

Lead Sponsor: Abbott Medical Devices

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

Status: COMPLETED

Sex: All

Target Recruitment: 870

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.).

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

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

Trial Locations

Locations (50): Fiona Stanley Hospital
🇦🇺
Murdoch, Western Australia, Australia
The Methodist Hospital
🇺🇸
Houston, Texas, United States
The Northern Hospital
🇦🇺
Epping, Victoria, Australia
QE II Health Sciences
🇨🇦
Halifax, Nova Scotia, Canada
National Heart Centre Singapore
🇸🇬
Singapore, Central, Singapore
Usman R. Siddiqui, MD
🇺🇸
Winter Park, Florida, United States
Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
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
University of Chicago
🇺🇸
Chicago, Illinois, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
IU Health Bloomington Hospital
🇺🇸
Bloomington, Indiana, United States
Iowa Heart Center
🇺🇸
West Des Moines, Iowa, United States
Providence Hospital
🇺🇸
Southfield, Michigan, United States
Charlton Memorial Hospital
🇺🇸
Fall River, Massachusetts, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
The Valley Hospital
🇺🇸
Ridgewood, New Jersey, United States
New Mexico Heart Institute
🇺🇸
Albuquerque, New Mexico, United States
New York University Hospital
🇺🇸
New York, New York, United States
Providence Heart & Vascular Institute
🇺🇸
Portland, Oregon, United States
Pinnacle Health System
🇺🇸
Harrisburg, Pennsylvania, United States
Lancaster General Hospital
🇺🇸
Lancaster, Pennsylvania, United States
Allegheny General Hospital - ASRI
🇺🇸
Pittsburgh, Pennsylvania, United States
Donald Guthrie Foundation for Education and Research
🇺🇸
Sayre, Pennsylvania, United States
Texas Cardiac Arrhythmia
🇺🇸
Austin, Texas, United States
University of Vermont College of Medicine
🇺🇸
Burlington, Vermont, United States
St. Joseph Medical Center
🇺🇸
Tacoma, Washington, United States
Mulgrave Private Hospital
🇦🇺
Mulgrave, Victoria, Australia
Universitätsklinik Graz
🇦🇹
Graz, Styria, Austria
CHUS Fleurimont
🇨🇦
Sherbrooke, Styria, Canada
Fakultni nemocnice Kralovske Vinohrady
🇨🇿
Prague, Central Bohemia, Czechia
Clinique Ambroise Pare
🇫🇷
Neuilly-sur-Seine, Ile-de-France, France
CHRU Rouen Hospital Charles Nicolle
🇫🇷
Rouen, Upper Normandy, France
Herzzentrum Leipzig GmbH
🇩🇪
Leipzig, Saxony, Germany
Herz-und Diabetes Zentrum NRW
🇩🇪
Bad Oeynhausen, Germany
Prince of Wales Hospital
🇭🇰
Hong Kong, Hong Kong SAR, Hong Kong
Fortis Memorial Research Institute
🇮🇳
Gurugramam, Haryana, India
Asian Institute of Gastroenterology (AIG) Hospital
🇮🇳
Hyderabad, India
Ospedale Generale Regionale F. Miulli
🇮🇹
Acquaviva Delle Fonti, Italy
Ospedale S.Maria della Misericordia
🇮🇹
Rovigo, Italy
Maastricht University Medical Center
🇳🇱
Maastricht, Netherlands
Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca
🇵🇱
Katowice, Poland
NG Teng Fong General Hospital
🇸🇬
Singapore, Central, Singapore
Christiaan Barnard Memorial Hospital
🇿🇦
Cape Town, South Africa
Hospital Universitario Virgen de la Nieves
🇪🇸
Granada, Spain
Hospital General Juan Ramon Jimenez
🇪🇸
Huelva, Spain
Center Inselspital Bern
🇨🇭
Bern, Switzerland
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States