Imaging Study of Lead Implant for His Bundle Pacing

Cardiac Pacemaker, Artificial Clinical Trial

— (IMAGE-HBP)  

Official title:

Imagining Study of Lead Implant for His Bundle Pacing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294317
• Other study ID #: IMAGE-HBP
• Status: Completed
• Start date: November 29, 2017
• Est. completion date: January 24, 2020

Study information

• Verified date: May 2021
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 24, 2020
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Pacemaker, Artificial

Intervention

Device:
• His bundle pacing
Medtronic SelectSecure SureScan MRI model 3830 lead

Locations

Country	Name	City	State
United States	Indiana University - Krannert Institute of Cardiology	Indianapolis	Indiana
United States	Virginia Commonwealth University Health System	Richmond	Virginia
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Changes in Impedance Over Time	To evaluate impedance from implant to 12 months	12 months
Secondary	Changes in R-wave Amplitude Over Time	To evaluate R-wave amplitude from implant to 12 months	12 months
Secondary	Changes in QRS Duration Over Time	Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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