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Imaging Study of Lead Implant for His Bundle Pacing ((IMAGE-HBP))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294317
Recruitment Status : Completed
First Posted : September 27, 2017
Results First Posted : June 1, 2021
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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Brief Summary:
The purpose of this research study is to assess the implant success proportion of the Medtronic SelectSecure MRI SureScan Model 3830 pacing lead at the bundle of His for His bundle pacing.

Condition or disease Intervention/treatment
Cardiac Pacemaker, Artificial Device: His bundle pacing

Detailed Description:
The study will evaluate implant lead electrical measurements and changes over time, estimate the correlation between lead location and selective vs non-selective His bundle pacing, and estimate the correlation between long-term lead performance and implant characteristics. Data from the study may be used to standardize the implant workflow to help improve the ease and predictability of His bundle pacing implants.
Study Design
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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imagining Study of Lead Implant for His Bundle Pacing
Actual Study Start Date : November 29, 2017
Actual Primary Completion Date : April 24, 2019
Actual Study Completion Date : January 24, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
His Bundle Pacing
Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.
 Device: His bundle pacing
Medtronic SelectSecure SureScan MRI model 3830 lead


Outcome Measures
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Primary Outcome Measures :
  1. Implant Success [ Time Frame: Day of implant ]
    To determine the proportion implant successes from all subjects who undergo an implant attempt of a lead at the bundle of His for His bundle pacing. Implant success will be defined as the presence of a H wave on the implanted lead EGM and a His-bundle pacing capture threshold equal to or less than 2.5V at 1.0ms.


Secondary Outcome Measures :
  1. Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant [ Time Frame: Day of implant ]
    Relationship between lead position (anterior septum, mid septum, posterior septum) and His-bundle pacing selectivity (selective vs. non-selective)

  2. Changes in His-bundle Pacing Capture Thresholds Over Time [ Time Frame: 12 months ]
    The change in the His-bundle pacing capture threshold from implant to 12 months

  3. Changes in Impedance Over Time [ Time Frame: 12 months ]
    To evaluate impedance from implant to 12 months

  4. Changes in R-wave Amplitude Over Time [ Time Frame: 12 months ]
    To evaluate R-wave amplitude from implant to 12 months

  5. Changes in QRS Duration Over Time [ Time Frame: 12 months ]
    Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up

  6. Association Between Lead Location and Long-term Lead Electrical Performance [ Time Frame: 12 months ]
    To assess the association between lead location and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.

  7. Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance [ Time Frame: 12 months ]
    To assess the correlation between His-bundle pacing capture threshold at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.

  8. Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance [ Time Frame: 12 months ]
    To assess the correlation between paced QRS duration at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.

  9. Complications Related to the Procedure or the Lead for His Bundle Pacing [ Time Frame: 12 months ]
    Adverse events that are complications related to the procedure or the lead for His bundle pacing will be summarized


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Bradycardia patients, AV Block patients, Sinus Node Dysfunction patients
Criteria

Inclusion Criteria:

  • Subject has a Class I or II indication for implantation of an implantable pacemaker
  • Subject (or legally authorized representative) has signed and dated the study-specific Consent Form
  • Subject is 18 years of age or older, or is of legal age to give informed consent per local and national law
  • Subject is expected to remain available for follow-up visits

Exclusion Criteria:

  • Subject is contraindicated for Cardiac CT
  • Subject has an existing or prior pacemaker, ICD or CRT device implant
  • Subject is intended to receive an implant of a LV lead or CRT device
  • Subject life expectancy is less than 1 year
  • Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence
  • Subjects with exclusion criteria required by local law (e.g. age or other)
  • Subject with a medical condition that precludes the patient from participation in the opinion of the investigator
  • Subject is enrolled in a concurrent study that may confound the results of this study.
Contacts and Locations
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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): NCT03294317


Locations
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United States, Indiana
Indiana University - Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202
United States, Pennsylvania
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Virginia
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: Pugazhendhi Vijayaraman, MD Geisinger Wyoming Valley Medical Center
  Study Documents (Full-Text)

Documents provided by Medtronic Cardiac Rhythm and Heart Failure:
Study Protocol  [PDF] March 19, 2018
Statistical Analysis Plan  [PDF] October 26, 2017
Informed Consent Form  [PDF] March 26, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03294317    
Other Study ID Numbers: IMAGE-HBP
First Posted: September 27, 2017    Key Record Dates
Results First Posted: June 1, 2021
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
His bundle pacing
Pacemaker