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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03719040
Registration number
NCT03719040
Ethics application status
Date submitted
23/10/2018
Date registered
25/10/2018
Date last updated
12/01/2022
Titles & IDs
Public title
Physiologic Pacing Registry
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Scientific title
Physiologic Pacing Registry
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Secondary ID [1]
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ABT-CIP-10270
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bradycardia
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Sinus Node Dysfunction
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Heart Block
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Syncope
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Cardiomyopathies
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Ventricular Tachycardia
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Heart Failure
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Cardiovascular
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Normal development and function of the cardiovascular system
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Cardiovascular
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Other cardiovascular diseases
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Physiologic pacing device implant characteristics
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Assessment method [1]
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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.
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Timepoint [1]
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During procedure
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Primary outcome [2]
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Physiologic pacing device implant follow-up characteristics
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Assessment method [2]
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Data will be collected to characterize the workflow, device system electrical performance and programming, and adverse events associated with HBP implants.
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Timepoint [2]
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6 Months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
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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.).
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/10/2021
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Sample size
Target
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Accrual to date
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Final
870
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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The Northern Hospital - Epping
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Recruitment hospital [2]
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Mulgrave Private Hospital - Mulgrave
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Recruitment hospital [3]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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3076 - Epping
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Recruitment postcode(s) [2]
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3170 - Mulgrave
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Recruitment postcode(s) [3]
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6150 - Murdoch
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Recruitment outside Australia
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United States of America
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Alabama
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California
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India
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Bern
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03719040
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clay Cohorn
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Address
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Abbott
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03719040
Download to PDF