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.
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 Type
OBSERVATIONAL
Enrollment
70
Medtronic SelectSecure SureScan MRI model 3830 lead
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
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.
Time frame: Day of implant
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)
Time frame: 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
Time frame: 12 months
Changes in Impedance Over Time
To evaluate impedance from implant to 12 months
Time frame: 12 months
Changes in R-wave Amplitude Over Time
To evaluate R-wave amplitude from implant to 12 months
Time frame: 12 months
Changes in QRS Duration Over Time
Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 12 months