Clinical Trial TitleThe fluoro-less HIS Bundle Pacing trial: Fluoroless permanent HIS Bundle Pacing utilizing electro-anatomic mapping versus conventional implantation.
Clinical Trial Protocol Description:
The goal of this study is to compare the safety, feasibility, accuracy and effectiveness of using electro-anatomic mapping (EAM) for permanent HIS Bundle Pacing (PHBP) procedures to PHBP cases performed without EAM using normal fluoroscopy-guided implant. Eligible patients will be randomly assigned to either EAM or fluoroscopically guided PHBP procedure. Patients will follow up for 3 months following the implant procedure. Approximately 20 participants from Rush University Medical Center will be enrolled into the study. Rush is the only site conducting this study.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age.
- Have been recommended by cardiologist for either a permanent pacemaker or CRT device implant.
You will be excluded from the study if any of the following criteria apply to you:
- Have an existing device (pacemaker or CRT).
- Are currently pregnant.
This is a partial list of elgibility requirements.