Imagining Study of Lead Implant for His Bundle Pacing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 3
- Primary Endpoint
- Implant Success
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Implant Success
Time Frame: 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 Outcomes
- Changes in His-bundle Pacing Capture Thresholds Over Time(12 months)
- Changes in QRS Duration Over Time(12 months)
- Changes in R-wave Amplitude Over Time(12 months)
- Changes in Impedance Over Time(12 months)
- Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant(Day of implant)
- Association Between Lead Location and Long-term Lead Electrical Performance(12 months)
- Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance(12 months)
- Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance(12 months)
- Complications Related to the Procedure or the Lead for His Bundle Pacing(12 months)