His-Bundle Corrective Pacing in Heart Failure (HIS-CRT)

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).

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Cardiac Resynchronization Therapy; Right Bundle-Branch Block; His-bundle Pacing
• Intervention / Treatment: Procedure: His-CRT implantation; Procedure: BIV-CRT implantation

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ann Colasurdo; Phone Number: 585-275-1054; Email: ann.colasurdo@heart.rochester.edu
• Study Contact Backup: Name: Mary Brown; Phone Number: 585-273-5283; Email: mary.brown@heart.rochester.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • University of Arizona
      • Principal Investigator: Roderick Tung
      • Contact: Mathew Freeman
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Kelsey Duggin
      • Principal Investigator: Eric Braunstein
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • University of South Florida
      • Contact: Jacky He
      • Principal Investigator: Bengt Herweg
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Samreen Ahmed
      • Principal Investigator: Timothy Larsen
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Shahram Sarrafi
      • Principal Investigator: Gaurav Upadhyay
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Memorial Hospital
      • Contact: Madison Stat
      • Principal Investigator: Nishant Verma
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • Recruiting
      • Valley Health System
      • Principal Investigator: Suneet Mittal
      • Contact: Sequoia Young
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Shahryar Kamran
      • Principal Investigator: Jacob Koruth
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medical College
      • Principal Investigator: Jim Cheung
      • Contact: Penn Collins
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Recruiting
      • Mission Health
      • Principal Investigator: Michael Manogue
      • Contact: Jordan Dalton
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Mary Gnap
      • Principal Investigator: Robert Schaller
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Recruiting
      • Geisinger Wyoming Valley
      • Contact: Grace Hughes
      • Principal Investigator: Pugazhendhi Vijayaraman
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Recruiting
      • University of Vermont
      • Contact: Amy Henderson
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University
      • Principal Investigator: Kenneth Ellenbogen
      • Contact: Anya Baranova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: His-CRT implantation; 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.
Active Comparator: 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.	Procedure: BIV-CRT implantation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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	6 months
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	6 months
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	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 24 months
Heart failure (HF) or death events	Assess heart Failure (HF)/death rates in the His-CRT vs. BIV-CRT arm	Up to 24 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Valentina Kutyifa, MD, PhD, University of Rochester; Principal Investigator: Roderick Tung, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Block; Pathological Conditions, Signs and Symptoms; Heart Failure; Bundle-Branch Block
• Other Study ID Numbers: STUDY 00007025; 1R01HL153390-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No