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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL153390-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| His-CRT implantation | Procedure | 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. |
| 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 |
| 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) |
| 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 |
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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ann Colasurdo | Contact | 585-275-1054 | ann.colasurdo@heart.rochester.edu | |
| Mary Brown | Contact | 585-273-5283 | mary.brown@heart.rochester.edu |
| Name | Affiliation | Role |
|---|---|---|
| Valentina Kutyifa, MD, PhD | University of Rochester | Principal Investigator |
| Roderick Tung, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Recruiting | Phoenix | Arizona | 85006 | United States |
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| BIV-CRT implantation | Procedure | 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. |
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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 |
Assess heart Failure (HF)/death rates in the His-CRT vs. BIV-CRT arm |
| Up to 24 months |
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| University of South Florida | Recruiting | Tampa | Florida | 33606 | United States |
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| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
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| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| Valley Health System | Recruiting | Ridgewood | New Jersey | 07450 | United States |
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| Weill Cornell Medical College | Recruiting | New York | New York | 10021 | United States |
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| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
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| Mission Health | Recruiting | Asheville | North Carolina | 28803 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Geisinger Wyoming Valley | Recruiting | Wilkes-Barre | Pennsylvania | 18711 | United States |
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| University of Vermont | Recruiting | Burlington | Vermont | 05401 | United States |
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| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
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| ID | Term |
|---|---|
| D002037 | Bundle-Branch Block |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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