Physiologic Pacing Registry

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT03719040

Collaborator

(none)

870

Enrollment

Locations

34.3

Actual Duration (Months)

17.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bradycardia Sinus Node Dysfunction Heart Block Syncope Cardiomyopathies Ventricular Tachycardia Heart Failure	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

870 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Physiologic Pacing Registry

Actual Study Start Date :

Nov 27, 2018

Actual Primary Completion Date :

Oct 7, 2021

Actual Study Completion Date :

Oct 7, 2021

Outcome Measures

Primary Outcome Measures

Physiologic pacing device implant characteristics [During procedure]
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.
Physiologic pacing device implant follow-up characteristics [6 Months]
Data will be collected to characterize the workflow, device system electrical performance and programming, and adverse events associated with HBP implants.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.).

Contacts and Locations

Locations

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