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

Imagining 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.

Study Overview

• Status: Completed
• Conditions: Cardiac Pacemaker, Artificial
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University - Krannert Institute of Cardiology
  • Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Wyoming Valley Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Bradycardia patients, AV Block patients, Sinus Node Dysfunction patients

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Success	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.	Day of implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant	Relationship between lead position (anterior septum, mid septum, posterior septum) and His-bundle pacing selectivity (selective vs. non-selective)	Day of implant
Changes in His-bundle Pacing Capture Thresholds Over Time	The change in the His-bundle pacing capture threshold from implant to 12 months	12 months
Changes in Impedance Over Time	To evaluate impedance from implant to 12 months	12 months
Changes in R-wave Amplitude Over Time	To evaluate R-wave amplitude from implant to 12 months	12 months
Changes in QRS Duration Over Time	Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up	12 months
Association Between Lead Location and Long-term Lead Electrical Performance	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.	12 months
Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance	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.	12 months
Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance	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.	12 months
Complications Related to the Procedure or the Lead for His Bundle Pacing	Adverse events that are complications related to the procedure or the lead for His bundle pacing will be summarized	12 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Pugazhendhi Vijayaraman, MD, Geisinger Wyoming Valley Medical Center

Publications and helpful links

General Publications

• Vijayaraman P, Dandamudi G, Subzposh FA, Shepard RK, Kalahasty G, Padala SK, Strobel JS, Bauch TD, Ellenbogen KA, Bergemann T, Hughes L, Harris ML, Fagan DH, Yang Z, Koneru JN; IMAGE-HBP Investigators. Imaging-Based Localization of His Bundle Pacing Electrodes: Results From the Prospective IMAGE-HBP Study. JACC Clin Electrophysiol. 2021 Jan;7(1):73-84. doi: 10.1016/j.jacep.2020.07.026. Epub 2020 Sep 30.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2017
• Primary Completion (Actual): April 24, 2019
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Pacemaker; His bundle pacing
• Other Study ID Numbers: IMAGE-HBP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes