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His Bundle Pacing Registry

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ClinicalTrials.gov Identifier: NCT03719040
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
The His Bundle Pacing registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) the His bundle pacing (HBP) device implant and follow-up workflows, including device and programmer measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of the His bundle prior to 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: His bundle pacing (HBP) device implant

Detailed Description:

The HBP Registry will be conducted to gain a deeper understanding of the HBP device implant and follow-up workflows. Additionally, the registry will provide a broader understanding of the clinical utility in mapping the His bundle with the use of Abbott's EnSite Precision™ Cardiac Mapping System with an electrophysiology catheter prior to device implants for those institutions where mapping is routine care prior to a HBP device implant.

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. The registry will enroll up to 500 patients at up to 50 sites worldwide and will collect data at implant and at 1 and 6 months post-implant. Abbott's His bundle pacing delivery catheter will be included and evaluated in this registry once approved by each participating country's regulatory body.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: His Bundle Pacing Registry
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: His bundle pacing (HBP) device implant

    Patients with cardiac disease may exhibit symptoms associated with electrical conduction abnormalities requiring implantation of a permanent cardiac pacing device. However, pacing is often associated with alteration of the normal electrical conduction system.

    An alternative and potentially more physiologic pacing strategy for patients with electrical conduction abnormalities is HBP - this is achieved by delivering pacing stimuli at the His bundle region with a permanent lead. HBP activates the heart through the native His-Purkinje conduction system, thus offering the most physiologic pacing approach to correct electrical dyssynchrony.



Primary Outcome Measures :
  1. HBP 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. HBP 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.



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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:

  • Scheduled for implantation of a de novo Abbott pacemaker, defibrillator, or CRT-P/D device with a pacing lead located at the His bundle 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
  • Previous failed HBP implant
  • Planned right-sided HBP implant
  • Life expectancy of < 6 months
  • Known contraindication for a HBP implant (i.e. ongoing infection, known inclusion 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
Contact: Jemymah C Morley +1 972-309-8503 jemymah.morley@abbott.com
Contact: Karolien Timmermans +32 2 774 67 41 Karolien.Timmermans@abbott.com

Locations
United States, Alabama
Heart Center Research, LLC. Recruiting
Huntsville, Alabama, United States, 35801
Contact: Jay Dinerman, MD         
United States, Pennsylvania
Donald Guthrie Foundation for Education and Research Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Pramod Deshmukh, MD         
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Clay Cohorn Abbott

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT03719040     History of Changes
Other Study ID Numbers: ABT-CIP-10270
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Tachycardia
Syncope
Tachycardia, Ventricular
Bradycardia
Heart Block
Sick Sinus Syndrome
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arrhythmia, Sinus