Physiologic Pacing Registry

NCT ID: NCT03719040

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 870 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2021-10-07

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Physiologic pacing device implant

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.

Intervention Type: DEVICE

Eligibility Criteria

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kwangdeok Lee

Role: STUDY_DIRECTOR

Abbott

Locations

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

Charlton Memorial Hospital

Fall River, Massachusetts, United States

Providence Hospital

Southfield, Michigan, 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

Duke University Medical Center

Durham, North Carolina, United States

Providence Heart & Vascular Institute

Portland, Oregon, United States

Geisinger Medical Center

Danville, Pennsylvania, 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

The Methodist Hospital

Houston, Texas, United States

University of Vermont College of Medicine

Burlington, Vermont, United States

St. Joseph Medical Center

Tacoma, Washington, United States

The Northern Hospital

Epping, Victoria, Australia

Mulgrave Private Hospital

Mulgrave, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Universitätsklinik Graz

Graz, Styria, Austria

QE II Health Sciences

Halifax, Nova Scotia, Canada

CHUS Fleurimont

Sherbrooke, Styria, Canada

Fakultni nemocnice Kralovske Vinohrady

Prague, Central Bohemia, Czechia

CHRU Rouen Hospital Charles Nicolle

Rouen, Upper Normandy, France

Clinique Ambroise Pare

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

National Heart Centre Singapore

Singapore, Central, Singapore

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

Countries

United States; Australia; Austria; Canada; Czechia; France; Germany; Hong Kong; India; Italy; Netherlands; Poland; Singapore; South Africa; Spain; Switzerland

References

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.

Reference Type: DERIVED

PMID: 37348800 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABT-CIP-10270

Identifier Type: -

Identifier Source: org_study_id