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His-Bundle Corrective Pacing in Heart Failure

ConditionsRight Bundle-Branch BlockHeart FailureHis-bundle PacingCardiac Resynchronization Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester

About this 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 heart failure and right bundle branch block (RBBB).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older (no upper age limit)

Optimal medical therapy for heart failure by current guidelines

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • His-CRT implantation

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: His-CRT implantationActive comparator 1 intervention
Group B: BIV-CRT implantationActive comparator 1 intervention

Trial outcomes

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)

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.

Time frame
6 month

Secondary outcomes

1

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

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

Time frame
6 months
2

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

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

Time frame
6 months
3

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

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

Time frame
6 months
4

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

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

Time frame
6 months

Other outcomes

1

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

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

Time frame
Up to 24 months
2

Heart failure (HF) or death events

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

Time frame
Up to 24 months

Sponsors and contacts

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University of Rochester

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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