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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Heart Block; Bradycardia; Syncope; Cardiomyopathies; Ventricular Tachycardia; Sinus Node Dysfunction
• Intervention / Treatment: Device: Physiologic pacing device implant

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.

• Study Type: Observational
• Enrollment (Actual): 870

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Epping, Victoria, Australia, 3076
      • The Northern Hospital
    • Mulgrave, Victoria, Australia, 3170
      • Mulgrave Private Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Universitätsklinik Graz
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • QE II Health Sciences
  • Styria
    • Sherbrooke, Styria, Canada, 8036
      • CHUS Fleurimont
• Czechia
  • Central Bohemia
    • Prague, Central Bohemia, Czechia, 100 34
      • Fakultní nemocnice Královské Vinohrady
• France
  • Ile-de-France
    • Neuilly-sur-Seine, Ile-de-France, France, 92200
      • Clinique Ambroise Paré
  • Upper Normandy
    • Rouen, Upper Normandy, France, 76031
      • CHRU Rouen Hospital Charles Nicolle
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Herz-und Diabetes Zentrum NRW
  • Saxony
    • Leipzig, Saxony, Germany, 04286
      • Herzzentrum Leipzig GmbH
• Hong Kong
  • Hong Kong SAR
    • Hong Kong, Hong Kong SAR, Hong Kong, 999077
      • Prince of Wales Hospital
• India
  • Hyderabad, India, 500032
    • Asian Institute of Gastroenterology (AIG) Hospital
  • Haryana
    • Gurugram, Haryana, India, 122002
      • Fortis Memorial Research Institute
• Italy
  • Acquaviva Delle Fonti, Italy, 70021
    • Ospedale Generale Regionale F. Miulli
  • Rovigo, Italy, 45100
    • Ospedale S.Maria della Misericordia
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
• Poland
  • Katowice, Poland, 40-635
    • Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca
• Singapore
  • Central
    • Singapore, Central, Singapore, 169609
      • National Heart Centre Singapore
    • Singapore, Central, Singapore, 609606
      • Ng Teng Fong General Hospital
• South Africa
  • Cape Town, South Africa, 8001
    • Christiaan Barnard Memorial Hospital
• Spain
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de la Nieves
  • Huelva, Spain, 21005
    • Hospital General Juan Ramon Jimenez
• Switzerland
  • Bern, Switzerland, 3010
    • Center Inselspital Bern
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research, LLC.
  • California
    • Burlingame, California, United States, 94010
      • Mills-Peninsula Medical Center
    • San Diego, California, United States, 92103
      • University of California at San Diego (UCSD) Medical Center
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Yoel R. Vivas, MD
    • Winter Park, Florida, United States, 32792
      • Usman R. Siddiqui, MD
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Indiana
    • Bloomington, Indiana, United States, 47403
      • IU Health Bloomington Hospital
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Fall River, Massachusetts, United States, 02720
      • Charlton Memorial Hospital
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Providence Hospital
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
  • New York
    • New York, New York, United States, 10016
      • New York University Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heart & Vascular Institute
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-2150
      • Geisinger Medical Center
    • Harrisburg, Pennsylvania, United States, 10016
      • Pinnacle Health System
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital - ASRI
    • Sayre, Pennsylvania, United States, 18840
      • Donald Guthrie Foundation for Education and Research
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
  • Vermont
    • Burlington, Vermont, United States, 05405-0068
      • University of Vermont College of Medicine
  • Washington
    • Tacoma, Washington, United States, 98405
      • St. Joseph Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The registry will include patients undergoing implantation of a pacemaker, defibrillator, or a cardiac resynchronization therapy (CRT) pacemaker (CRT-P) or CRT defibrillator (CRT-D) according to the clinical site's routine care.

Description

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.).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiologic pacing device implant characteristics	Data will be collected to characterize the workflow, success, and complications associated with standard-of-care HBP implants in patients indicated for a pacemaker, defibrillator, or CRT device. Data will be compared with and without the use of the EnSite Precision Mapping System used according to each site's routine care.	During procedure
Physiologic pacing device implant follow-up characteristics	Data will be collected to characterize the workflow, device system electrical performance and programming, and adverse events associated with HBP implants.	6 Months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 27, 2018
• Primary Completion (ACTUAL): October 7, 2021
• Study Completion (ACTUAL): October 7, 2021

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (ACTUAL): October 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Unconsciousness; Consciousness Disorders; Arrhythmia, Sinus; Heart Block; Bradycardia; Tachycardia; Tachycardia, Ventricular; Cardiomyopathies; Syncope; Sick Sinus Syndrome
• Other Study ID Numbers: ABT-CIP-10270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes