His-Bundle Corrective Pacing in Heart Failure

Not Applicable

Recruiting

• Conditions: His-bundle Pacing; Right Bundle-Branch Block; Heart Failure; Cardiac Resynchronization Therapy
• Interventions: Procedure: His-CRT implantation; Procedure: BIV-CRT implantation

• Registration Number: NCT05265520
• Lead Sponsor: University of Rochester

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-03-03
• Study Start: 2022-12-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07
• Primary Completion: 2026-01-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
His-CRT implantation	His-CRT implantation	His-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an endocardial His-bundle pacing leads directly pacing the intrinsic conduction system.
BIV-CRT implantation	BIV-CRT implantation	BIV-CRT implantation includes implantation of three leads, 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 Outcome Measures

Name	Time	Method
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)	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 Outcome Measures

Name	Time	Method
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-systolic volume (LVESV)	6 months	Secondary endpoint measured from echocardiography on left ventricular end-systolic volume (LVESV) in the His-CRT vs. BIV-CRT arm
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-diastolic volume (LVEDV)	6 months	Secondary endpoint measured from echocardiography on left ventricular end-diastolic volume (LVEDV) in the His-CRT vs. BIV-CRT arm
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in ECG biomarkers	6 months	Secondary endpoint measured on a continuous scale of paced ventricular depolarization (QRS) duration in the His-CRT vs. BIV-CRT arm
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in NT-proBNP	6 months	Secondary endpoint of NT-proBNP in the His-CRT vs. BIV-CRT arm

Trial Locations

Locations (3)

Valley Health System; 🇺🇸 Paramus, New Jersey, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States