Physiologic Pacing Registry

Heart Failure Clinical Trial

Official title:

Physiologic Pacing Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719040
• Other study ID #: ABT-CIP-10270
• Status: Completed
• Start date: November 27, 2018
• Est. completion date: October 7, 2021

Study information

• Verified date: January 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 870
• Est. completion date: October 7, 2021
• Est. primary completion date: October 7, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Bradycardia
• Cardiomyopathies
• Heart Block
• Heart Failure
• Sick Sinus Syndrome
• Sinus Node Dysfunction
• Syncope
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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