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His-Bundle Corrective Pacing in Heart Failure

Recruiting
18 years of age
Both
Phase N/A

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Overview

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).

Description

In this prospective, randomized, multi-center clinical trial, 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 Right Bundle Branch Block (RBBB) Electrocardiogram (ECG) Pattern by assessing the improvement in left ventricular ejection fraction (LVEF) in the His-CRT vs. BIV-CRT arm at 6 months, and by evaluating changes in ECG biomarkers, NT-pro-brain natriuretic peptide (NT-proBNP) levels, and echocardiography biomarkers (left ventricular volumes, strain contractility, and dyssynchrony), as well as temporal changes in functional status and quality of life in the His-CRT vs. BIV-CRT arm at 6, 12, and 24 months.

Eligibility

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

Study details

Right Bundle-Branch Block, Heart Failure, His-bundle Pacing, Cardiac Resynchronization Therapy

NCT05265520

University of Rochester

25 January 2024

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