Clinical trial NCT03294317: Imaging Study of Lead Implant for His Bundle Pacing
Official title: Imagining Study of Lead Implant for His Bundle Pacing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Pacemaker, Artificial
Keywords: His bundle pacing
Pacemaker
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2017-09-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bradycardia patients, AV Block patients, Sinus Node Dysfunction patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implant Success
timeFrame: Day of implant
Secondary outcomes:
measure: Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant
timeFrame: Day of implant
measure: Changes in His-bundle Pacing Capture Thresholds Over Time
timeFrame: 12 months
measure: Changes in Impedance Over Time
timeFrame: 12 months
measure: Changes in R-wave Amplitude Over Time
timeFrame: 12 months
measure: Changes in QRS Duration Over Time
timeFrame: 12 months
measure: Association Between Lead Location and Long-term Lead Electrical Performance
timeFrame: 12 months
measure: Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance
timeFrame: 12 months
measure: Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance
timeFrame: 12 months
measure: Complications Related to the Procedure or the Lead for His Bundle Pacing
timeFrame: 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University - Krannert Institute of Cardiology
state: Indiana
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
Study officials:
affiliation: Geisinger Wyoming Valley Medical Center
name: Pugazhendhi Vijayaraman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.