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His-Bundle Corrective Pacing in Heart Failure

Sponsored by University of Rochester

About this study

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).

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.

Where this study is enrolling (5)

Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.