NCT03294317: (IMAGE-HBP)

Imaging Study of Lead Implant for His Bundle Pacing

Completed Results posted Last updated 1 June 2021

What this trial tests

trial testing His bundle pacing in Cardiac Pacemaker, Artificial in 70 participants. Completed in 24 January 2020.

Timeline

29 November 2017

Primary endpoint
24 April 2019

24 January 2020

Quick facts

Lead sponsor	Medtronic Cardiac Rhythm and Heart Failure
Status	Completed
Study type	OBSERVATIONAL
Enrollment	70
Start date	29 November 2017
Primary completion	24 April 2019
Estimated completion	24 January 2020
Sites	3 locations across United States

Drugs / interventions tested

• His bundle pacing

Conditions studied

• Cardiac Pacemaker, Artificial — all drugs for Cardiac Pacemaker, Artificial →

Sponsor

Medtronic Cardiac Rhythm and Heart Failure — full company profile →

Who can join

18 and older, any sex, with Cardiac Pacemaker, Artificial. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Implant Success Primary · 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.

Group	Value	95% CI
His Bundle Pacing	75.36	64.04 – 84.01

Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant Secondary · Day of implant

Relationship between lead position (anterior septum, mid septum, posterior septum) and His-bundle pacing selectivity (selective vs. non-selective)

Atrial/Ventricular side of TV annulus

Group	Value	95% CI
His Bundle Pacing	1.27	0.24 – 6.58

Above/Below side of CS/RV line

Group	Value	95% CI
His Bundle Pacing	0.57	0.14 – 2.29

Changes in His-bundle Pacing Capture Thresholds Over Time Secondary · 12 months

The change in the His-bundle pacing capture threshold from implant to 12 months

Group	Value	95% CI
His Bundle Pacing	1.82	± 1.03

Changes in Impedance Over Time Secondary · 12 months

To evaluate impedance from implant to 12 months

Group	Value	95% CI
His Bundle Pacing	429.72	± 79.29

Changes in R-wave Amplitude Over Time Secondary · 12 months

To evaluate R-wave amplitude from implant to 12 months

Group	Value	95% CI
His Bundle Pacing	4.10	± 2.15

Changes in QRS Duration Over Time Secondary · 12 months

Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up

Group	Value	95% CI
His Bundle Pacing	105.00	± 32.05

Association Between Lead Location and Long-term Lead Electrical Performance Secondary · 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.

Atrial/Ventricular side of TV annulus

Group	Value	95% CI
His Bundle Pacing	0.070681015	-0.587845 – 0.729207

Above/Below side of CS/RV line

Group	Value	95% CI
His Bundle Pacing	0.106436807	-0.439328 – 0.652202

Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance Secondary · 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.

Group	Value	95% CI
His Bundle Pacing	0.308729841	0.008103 – 0.609357

Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance Secondary · 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.

Group	Value	95% CI
His Bundle Pacing	-0.001329355	-0.012422 – 0.009763

Complications Related to the Procedure or the Lead for His Bundle Pacing Secondary · 12 months

Adverse events that are complications related to the procedure or the lead for His bundle pacing will be summarized

Group	Value	95% CI
His Bundle Pacing	4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected over a period of 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

His Bundle Pacing

Serious: 3/69 (4%)

Deaths: 0/69

Serious adverse events (2 terms)

Reaction	System	His Bundle Pacing
Device pacing issue	Cardiac disorders	—
Device capturing issue	Cardiac disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	His Bundle Pacing
Bundle branch block right	Cardiac disorders	—
Device pacing issue	Cardiac disorders	—

Most-reported serious reactions: Device pacing issue, Device capturing issue.

Data from ClinicalTrials.gov NCT03294317 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Imaging-Based Localization of His Bundle Pacing Electrodes: Results From the Prospective IMAGE-HBP Study.
   Vijayaraman P, Dandamudi G, Subzposh FA, Shepard RK, et al · · 2021 · cited 19× · PMID 33478715 · DOI 10.1016/j.jacep.2020.07.026