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NCT Number: NCT05265520

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).

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Key information

Conditions

Right Bundle-Branch Block Arrhythmias, Cardiac Bundle-Branch Block Cardiac Conduction System Disease Cardiac Resynchronization Therapy Cardiovascular Diseases Heart Block Heart Diseases Heart Failure His-bundle Pacing Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

His-CRT implantation

Procedure

The pathophysiological process is utilized in His-Bundle corrective pacing, resulting in a faster and more homogeneous activation of the heart pacing directly via the intrinsic conduction system of the heart accompanied by a right atrial endocardial lead and a right ventricular endocardial lead.

BIV-CRT implantation

Procedure

Biventricular cardiac resynchronization therapy has been shown to improve outcomes by delivering synchronized electrical stimuli to the right and left ventricles utilizing an an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.

Primary outcomes

  1. Change in Left Ventricular Ejection Fraction at 6 months with His-CRT vs. BIV-CRT, in heart failure patients with Right bundle branch block (RBBB)

    Time frame: 6 month

    The effect of His-CRT vs. BIV-CRT on left ventricular ejection fraction (as a percentage) measured during an echocardiography imaging study will be analyzed using an analysis of covariance model for changes in LVEF from pre-implantation (baseline) to post-implantation (6 months follow-up), with randomized treatment group as the factor of interest, and baseline LVEF as a covariate. A t-test will be performed using this model to compare the adjusted group means, and a confidence interval will be constructed for their difference.

Secondary outcomes

  1. Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in ECG biomarkers

    Time frame: 6 months

    Secondary endpoint measured on a continuous scale of paced ventricular depolarization (QRS) duration in the His-CRT vs. BIV-CRT arm

  2. Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-systolic volume (LVESV)

    Time frame: 6 months

    Secondary endpoint measured from echocardiography on left ventricular end-systolic volume (LVESV) in the His-CRT vs. BIV-CRT arm

  3. Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-diastolic volume (LVEDV)

    Time frame: 6 months

    Secondary endpoint measured from echocardiography on left ventricular end-diastolic volume (LVEDV) in the His-CRT vs. BIV-CRT arm

  4. Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in NT-proBNP

    Time frame: 6 months

    Secondary endpoint of NT-proBNP in the His-CRT vs. BIV-CRT arm

Other outcomes

  1. Ascertain the mechanism of benefit on ventricular depolarization (QRS duration) over time, at 6 months, 12 months, and 24 months.

    Time frame: Up to 24 months

    Assessing changes in QRS duration at 6, 12, 24 months in the His-CRT vs. BIV-CRT arm

  2. Heart failure (HF) or death events

    Time frame: Up to 24 months

    Assess heart Failure (HF)/death rates in the His-CRT vs. BIV-CRT arm

Study contacts

Contact information is provided by the study sponsor or research team.

Ann Colasurdo

CONTACT

[email protected]

585-275-1054

Mary Brown

CONTACT

[email protected]

585-273-5283

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Acronym: HIS-CRT

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Mar 3, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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