RecruitingRecruiting
His-Bundle Corrective Pacing in Heart Failure
NCT05265520 · University of Rochester
In plain English
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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.
Eligibility criteria
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
Enrollment target: 120 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2022-12-02
Estimated completion: 2028-07-01
Last updated: 2026-02-09
Interventions
Procedure: His-CRT implantationProcedure: BIV-CRT implantation
Primary outcomes
- • 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)
Sponsor
University of Rochester · other
With: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Contacts & investigators
ContactAnn Colasurdo · contact · ann.colasurdo@heart.rochester.edu · 585-275-1054
ContactMary Brown · contact · mary.brown@heart.rochester.edu · 585-273-5283
InvestigatorValentina Kutyifa, MD, PhD · principal_investigator, University of Rochester
InvestigatorRoderick Tung, MD · principal_investigator, University of Arizona
All locations (14)
University of ArizonaRecruiting
Phoenix, Arizona, United States
Cedars-Sinai Medical CenterRecruiting
Los Angeles, California, United States
University of South FloridaRecruiting
Tampa, Florida, United States
Northwestern Memorial HospitalRecruiting
Chicago, Illinois, United States
Rush University Medical CenterRecruiting
Chicago, Illinois, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Valley Health SystemRecruiting
Ridgewood, New Jersey, United States
Weill Cornell Medical CollegeRecruiting
New York, New York, United States
Mount Sinai HospitalRecruiting
New York, New York, United States
Mission HealthRecruiting
Asheville, North Carolina, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Geisinger Wyoming ValleyRecruiting
Wilkes-Barre, Pennsylvania, United States
University of VermontRecruiting
Burlington, Vermont, United States
Virginia Commonwealth UniversityRecruiting
Richmond, Virginia, United States