Imaging Study of Lead Implant for His Bundle Pacing

Completed

Conditions: Cardiac Pacemaker, Artificial

Registration Number: NCT03294317

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 70

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant Success	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

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

Trial Locations

Locations (3): Indiana University - Krannert Institute of Cardiology
🇺🇸
Indianapolis, Indiana, United States
Geisinger Wyoming Valley Medical Center
🇺🇸
Wilkes-Barre, Pennsylvania, United States
Virginia Commonwealth University Health System
🇺🇸
Richmond, Virginia, United States
Indiana University - Krannert Institute of Cardiology
🇺🇸Indianapolis, Indiana, United States