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His-Bundle Corrective Pacing in Heart Failure
The investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with heart failure and right bundle branch block (RBBB).
Conditions:
🦠 Right Bundle-Branch Block 🦠 Heart Failure 🦠 His-bundle Pacing 🦠 Cardiac Resynchronization Therapy
🗓️ Study Start (Actual) 2 December 2022
🗓️ Primary Completion (Estimated) 1 January 2026
✅ Study Completion (Estimated) 1 July 2027
👥 Enrollment (Estimated) 120
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chicago, Illinois, United States
📍 Paramus, New Jersey, United States
📍 Burlington, Vermont, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age 18 years or older (no upper age limit)
    • * Optimal medical therapy for heart failure by current guidelines
    • * Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:
    • * New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR
    • * NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR
    • * NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration 120-149 ms (IIb)

    Exclusion Criteria:

    • * Unable to obtain most recent imaging data from echocardiogram within 1 year prior to date of randomization
    • * Left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) ECG morphology
    • * Unable or unwilling to follow study protocol
    • * Less than 12 months life expectancy at consent
    • * Pregnancy or planned pregnancy during duration of the study
    • * On heart transplant list or likely to undergo heart transplant
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 10 February 2022
  • First Submitted that Met QC Criteria 22 February 2022
  • First Posted 3 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 January 2024
  • Last Update Posted 5 January 2024
  • Last Verified January 2024
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