His Bundle Pacing in Bradycardia and Heart Failure
Participants in this study will either have heart failure (HF) and are scheduled to undergo pace maker (PM) implantation, cardiac resynchronization therapy pacemaker (CRT-P), cardiac resynchronization therapy defibrillator (CRT-D) implantation, His bundle pacing (HIBP) or left bundle area pacing (LBAP) (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders), or have atrioventricular (AV) block or bradycardia and are scheduled to undergo dual chamber pacemaker implantation. In this study additional heart rhythm measurements will be collected during the implant procedure to better understand how His bundle and/or parahisian pacing (HISP) effects electrical conduction in the hearts of patients with HF or AV block. The hypothesis is that His bundle or parahisian pacing (HISP) and left bundle area pacing (LBAP) may normalize atrioventricular (AV) conduction with a narrow combination of the Q wave, R wave and S wave (QRS complex) in functional bundle branch block or conduction delay in patients with heart failure (HF).
Conditions:
🦠 Bradycardia 🦠 Heart Failure
🗓️ Study Start (Actual) October 2016
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 80
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • HF Group
    • * Clinically recommended to undergo PM, CRT-P, or CRT-D implantation or HIBP/LBAP (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders)
    • * Any QRS duration
    • * LVEF ≤ 50%
    • AV Block/Bradycardia Group
    • * Recommended to undergo dual chamber pacemaker implantation
    • * Second or third degree AV block or Sinus Bradycardia

    Exclusion Criteria:

    • * Age \< 18 years
    • * Pregnant
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 November 2016
  • First Submitted that Met QC Criteria 30 December 2016
  • First Posted 2 January 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 January 2024
  • Last Update Posted 1 February 2024
  • Last Verified January 2024