Imaging Study of Lead Implant for His Bundle Pacing

Study Overview
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Brief Summary
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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
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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.

Official Title
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Imagining Study of Lead Implant for His Bundle Pacing

Conditions
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Cardiac Pacemaker, Artificial

Intervention / Treatment
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* Device: His bundle pacing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| His Bundle Pacing<br>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted. | Device: His bundle pacing<br>* Medtronic SelectSecure SureScan MRI model 3830 lead<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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His bundle pacing, Pacemaker