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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03719040




Registration number
NCT03719040
Ethics application status
Date submitted
23/10/2018
Date registered
25/10/2018

Titles & IDs
Public title
Physiologic Pacing Registry
Scientific title
Physiologic Pacing Registry
Secondary ID [1] 0 0
ABT-CIP-10270
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bradycardia 0 0
Sinus Node Dysfunction 0 0
Heart Block 0 0
Syncope 0 0
Cardiomyopathies 0 0
Ventricular Tachycardia 0 0
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Physiologic pacing device implant

Treatment: Devices: 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 code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Physiologic Pacing Implant Success Rate
Timepoint [1] 0 0
During procedure
Primary outcome [2] 0 0
Pacing Capture Threshold for His Bundle Pacing
Timepoint [2] 0 0
6 Months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/10/2021
Sample size
Target
Accrual to date
Final
870
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
The Northern Hospital - Epping
Recruitment hospital [2] 0 0
Mulgrave Private Hospital - Mulgrave
Recruitment hospital [3] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
3076 - Epping
Recruitment postcode(s) [2] 0 0
3170 - Mulgrave
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Vermont
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Austria
State/province [18] 0 0
Styria
Country [19] 0 0
Canada
State/province [19] 0 0
Nova Scotia
Country [20] 0 0
Canada
State/province [20] 0 0
Styria
Country [21] 0 0
Czechia
State/province [21] 0 0
Central Bohemia
Country [22] 0 0
France
State/province [22] 0 0
Ile-de-France
Country [23] 0 0
France
State/province [23] 0 0
Upper Normandy
Country [24] 0 0
Germany
State/province [24] 0 0
Saxony
Country [25] 0 0
Germany
State/province [25] 0 0
Bad Oeynhausen
Country [26] 0 0
Hong Kong
State/province [26] 0 0
Hong Kong SAR
Country [27] 0 0
India
State/province [27] 0 0
Haryana
Country [28] 0 0
India
State/province [28] 0 0
Hyderabad
Country [29] 0 0
Italy
State/province [29] 0 0
Acquaviva Delle Fonti
Country [30] 0 0
Italy
State/province [30] 0 0
Rovigo
Country [31] 0 0
Netherlands
State/province [31] 0 0
Maastricht
Country [32] 0 0
Poland
State/province [32] 0 0
Katowice
Country [33] 0 0
Singapore
State/province [33] 0 0
Central
Country [34] 0 0
South Africa
State/province [34] 0 0
Cape Town
Country [35] 0 0
Spain
State/province [35] 0 0
Granada
Country [36] 0 0
Spain
State/province [36] 0 0
Huelva
Country [37] 0 0
Switzerland
State/province [37] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kwangdeok Lee
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03719040