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Completed

NCT Number: NCT03294317

Imaging Study of Lead Implant for His Bundle Pacing

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.

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Key information

Conditions

Cardiac Pacemaker, Artificial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University - Krannert Institute of Cardiology, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

His bundle pacing

Device

Medtronic SelectSecure SureScan MRI model 3830 lead

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Imagining Study of Lead Implant for His Bundle Pacing

Acronym: (IMAGE-HBP)

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 27, 2017
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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