His-Bundle Corrective Pacing in Heart Failure
HIS-CRT
2 other identifiers
interventional
120
1 country
14
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2022
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 3, 2022
CompletedStudy Start
First participant enrolled
December 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
February 9, 2026
February 1, 2026
4.6 years
February 10, 2022
February 4, 2026
Conditions
Outcome Measures
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.
6 month
Secondary Outcomes (4)
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in ECG biomarkers
6 months
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-systolic volume (LVESV)
6 months
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-diastolic volume (LVEDV)
6 months
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in NT-proBNP
6 months
Other Outcomes (2)
Ascertain the mechanism of benefit on ventricular depolarization (QRS duration) over time, at 6 months, 12 months, and 24 months.
Up to 24 months
Heart failure (HF) or death events
Up to 24 months
Study Arms (2)
His-CRT implantation
ACTIVE COMPARATORHis-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
ACTIVE COMPARATORBIV-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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- University of Rochesterlead
- National Institutes of Health (NIH)collaborator
Study Sites (14)
University of Arizona
Phoenix, Arizona, 85006, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of South Florida
Tampa, Florida, 33606, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Valley Health System
Ridgewood, New Jersey, 07450, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Mission Health
Asheville, North Carolina, 28803, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711, United States
University of Vermont
Burlington, Vermont, 05401, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valentina Kutyifa, MD, PhD
University of Rochester
- PRINCIPAL INVESTIGATOR
Roderick Tung, MD
University of Arizona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
February 10, 2022
First Posted
March 3, 2022
Study Start
December 2, 2022
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
February 9, 2026
Record last verified: 2026-02