Physiologic Pacing Registry

NCT03719040 | Completed Results FDA Device

• 1 other identifier: ABT-CIP-10270
• Study Type: observational
• Target: 870
• Locations: 15 countries
• Sites: 49

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.

Conditions

Bradycardia; Sinus Node Dysfunction; Heart Block; Syncope; Cardiomyopathies; Ventricular Tachycardia; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Physiologic Pacing Implant Success Rate

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

  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.

  6 Months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (50)

Heart Center Research, LLC.

Huntsville, Alabama, 35801, United States

Location

Mills-Peninsula Medical Center

Burlingame, California, 94010, United States

Location

University of California at San Diego (UCSD) Medical Center

San Diego, California, 92103, United States

Location

Yoel R. Vivas, MD

Delray Beach, Florida, 33484, United States

Location

Usman R. Siddiqui, MD

Winter Park, Florida, 32792, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

IU Health Bloomington Hospital

Bloomington, Indiana, 47403, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Charlton Memorial Hospital

Fall River, Massachusetts, 02720, United States

Location

Providence Hospital

Southfield, Michigan, 48075, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

New York University Hospital

New York, New York, 10016, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Providence Heart & Vascular Institute

Portland, Oregon, 97225, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2150, United States

Location

Pinnacle Health System

Harrisburg, Pennsylvania, 10016, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Allegheny General Hospital - ASRI

Pittsburgh, Pennsylvania, 15212, United States

Location

Donald Guthrie Foundation for Education and Research

Sayre, Pennsylvania, 18840, United States

Location

Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Vermont College of Medicine

Burlington, Vermont, 05405-0068, United States

Location

St. Joseph Medical Center

Tacoma, Washington, 98405, United States

Location

The Northern Hospital

Epping, Victoria, 3076, Australia

Location

Mulgrave Private Hospital

Mulgrave, Victoria, 3170, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Universitätsklinik Graz

Graz, Styria, 8036, Austria

Location

QE II Health Sciences

Halifax, Nova Scotia, B3H 3A7, Canada

Location

CHUS Fleurimont

Sherbrooke, Styria, 8036, Canada

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, Central Bohemia, 100 34, Czechia

Location

CHRU Rouen Hospital Charles Nicolle

Rouen, Upper Normandy, 76031, France

Location

Clinique Ambroise Pare

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location

Herzzentrum Leipzig GmbH

Leipzig, Saxony, 04286, Germany

Location

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Prince of Wales Hospital

Hong Kong, Hong Kong SAR, 999077, Hong Kong

Location

Fortis Memorial Research Institute

Gurugramam, Haryana, 122002, India

Location

Asian Institute of Gastroenterology (AIG) Hospital

Hyderabad, 500032, India

Location

Ospedale Generale Regionale F. Miulli

Acquaviva delle Fonti, 70021, Italy

Location

Ospedale S.Maria della Misericordia

Rovigo, 45100, Italy

Location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Location

Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca

Katowice, 40-635, Poland

Location

National Heart Centre Singapore

Singapore, Central, 169609, Singapore

Location

NG Teng Fong General Hospital

Singapore, Central, 609606, Singapore

Location

Christiaan Barnard Memorial Hospital

Cape Town, 8001, South Africa

Location

Hospital Universitario Virgen de la Nieves

Granada, 18014, Spain

Location

Hospital General Juan Ramon Jimenez

Huelva, 21005, Spain

Location

Center Inselspital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

• Vazquez PM, Mohamed U, Zanon F, Lustgarten DL, Atwater B, Whinnett ZI, Curila K, Dinerman J, Molina-Lerma M, Wiley J, Grammatico A, Lee K, Vijayaraman P. Result of the Physiologic Pacing Registry, an international multicenter prospective observational study of conduction system pacing. Heart Rhythm. 2023 Dec;20(12):1617-1625. doi: 10.1016/j.hrthm.2023.06.006. Epub 2023 Jun 20.

  PMID: 37348800 DERIVED

MeSH Terms

Conditions

Bradycardia; Sick Sinus Syndrome; Heart Block; Syncope; Cardiomyopathies; Tachycardia, Ventricular; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmia, Sinus; Cardiac Conduction System Disease; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Tachycardia

Results Point of Contact

• Title: Dr. Kwangdeok Lee
• Organization: Abbott

kwangdeok.lee@abbott.com

9725269673

Study Officials

• Kwangdeok Lee

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 25, 2018
• Study Start: November 27, 2018
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-08

Locations

CA (2); AU (3); FR (2); IT (2); HK (1); PL (1); DE (2); ES (2); US (26); NL (1); SG (2); CH (1); IN (2); ZA (1); CZ (1)