Right Bundle-Branch BlockHIS-CRTNCT05265520
His-Bundle Corrective Pacing in Heart Failure
A study testing His-CRT implantation and BIV-CRT implantation in people with Right Bundle-Branch Block and Heart Failure, run by University of Rochester at 14 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Bundle-Branch Block, Heart Failure, His-bundle Pacing
- What is being tested?
- His-CRT implantation and BIV-CRT implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 14 sitesUnited States
- Study dates
- 2 Dec 2022to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
Mission Health
Asheville, North Carolina, 28803
Jordan Dalton
Michael Manogue
- Recruiting
University of Vermont
Burlington, Vermont, 05401
Amy Henderson
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Madison Stat
Nishant Verma
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Samreen Ahmed
Timothy Larsen
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Shahram Sarrafi
Gaurav Upadhyay
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Kelsey Duggin
Eric Braunstein
- Recruiting
Weill Cornell Medical College
New York, New York, 10021
Penn Collins
Jim Cheung
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Shahryar Kamran
Jacob Koruth
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mary Gnap
Robert Schaller
- Recruiting
University of Arizona
Phoenix, Arizona, 85006
Mathew Freeman
Roderick Tung
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Anya Baranova
Kenneth Ellenbogen
- Recruiting
Valley Health System
Ridgewood, New Jersey, 07450
Sequoia Young
Suneet Mittal
- Recruiting
University of South Florida
Tampa, Florida, 33606
Jacky He
Bengt Herweg
- Recruiting
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711
Grace Hughes
Pugazhendhi Vijayaraman
About this study
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).
Read the 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.
- Conditions
- Right Bundle-Branch Block, Heart Failure, His-bundle Pacing, Cardiac Resynchronization Therapy
- Being tested
- His-CRT implantation, BIV-CRT implantation
- Medical subject headings
- Bundle-Branch Block, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
His-CRT implantationProcedure or 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 implantationProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| His-CRT implantation | Active comparator | 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. Receives: Procedure: His-CRT implantation |
| BIV-CRT implantation | Active comparator | 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. Receives: Procedure: BIV-CRT implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start2 Dec 2022
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Bundle-Branch BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Valentina Kutyifa, University of Rochester
- Investigators
- Valentina Kutyifa, MD, PhD, Principal investigator, University of RochesterRoderick Tung, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265520
- Sponsor's protocol ID
- STUDY 00007025
- Other IDs
- 1R01HL153390-01A1
- Acronym
- HIS-CRT
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2022
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- His-Bundle Corrective Pacing in Heart Failure
- ClinicalTrials.gov ID
- NCT05265520
- Acronym / sponsor ID
- HIS-CRT / STUDY 00007025
- Conditions
- Right Bundle-Branch Block, Heart Failure, His-bundle Pacing, Cardiac Resynchronization Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| His-CRT implantation | Active comparator | Procedure: His-CRT implantationHis-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 comparator | Procedure: BIV-CRT implantationBIV-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| His-CRT implantationThe 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. | Procedure or surgery | His-CRT implantation |
| BIV-CRT implantationBiventricular 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. | Procedure or surgery | BIV-CRT implantation |
Primary outcome
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)
Time frame: 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.
4 secondary outcomes
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in ECG biomarkers
Time frame: 6 months
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-systolic volume (LVESV)
Time frame: 6 months
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-diastolic volume (LVEDV)
Time frame: 6 months
Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in NT-proBNP
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valentina Kutyifa, MD, PhD principal investigator
University of Rochester
Roderick Tung, MD principal investigator
University of Arizona
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing His-CRT implantation and BIV-CRT implantation in people with Right Bundle-Branch Block and Heart Failure, run by University of Rochester at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Colasurdo (585-275-1054, ann.colasurdo@heart.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.