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Physiologic Pacing Registry

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ClinicalTrials.gov Identifier: NCT03719040
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Physiologic Pacing Registry
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : November 21, 2021
Estimated Study Completion Date : May 21, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Physiologic pacing device implant characteristics [ Time Frame: 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.

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The registry will include patients undergoing implantation of a pacemaker, defibrillator, or a cardiac resynchronization therapy (CRT) pacemaker (CRT-P) or CRT defibrillator (CRT-D) according to the clinical site's routine care.
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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719040


Contacts
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Contact: Jemy C Allen +1 972-309-8503 jemymah.allen@abbott.com
Contact: Anuja Kulkarni +1 408-845-8275 anuja.kulkarni@abbott.com

Locations
Show Show 20 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Clay Cohorn Abbott
Additional Information:

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03719040    
Other Study ID Numbers: ABT-CIP-10270
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Syncope
Cardiomyopathies
Tachycardia
Tachycardia, Ventricular
Bradycardia
Heart Block
Sick Sinus Syndrome
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Arrhythmia, Sinus