Cardiac Resynchronization Therapy Using His/Left Bundle Branch Pacing vs Biventricular Pacing With a Left Ventricular Epicardial Lead in Patients With Heart Failure (HF) With Left Ventricular Ejection Fraction (LVEF)≤50% and With Either a Wide QRS Complex (>130 ms) or With/Anticipated >40% Pacing Randomized Clinical Trial
Tony Navarrete
Primary Investigator
Brief description of study
What is this study about?
Cardiac-resynchronization therapy (CRT) is a type of heart failure (HF) treatment that improves the way your heart works, improves your ability to exercise, reduces hospitalization, and lengthens your lifespan. CRT can be delivered by pacing in one of two different configurations: biventricular pacing (BiVP) or pacing at a place called the His or left bundle branch. The purpose of this study is to compare the two pacing treatments - BiVP and His/LBBP - to determine if one is better than the other.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants who are stable on medications for heart failure therapy and meet the criteria for a CRT device will be referred by their treating physicians to the study team to determine if they are eligible and are willing to participate.
Detailed description of study
What happens during study participation?
Participants will be randomly assigned (like flipping a coin) to one of two treatments (A or B), both of which are standard of care heart pacing treatments:
A. Pacing the heart from two locations in the left ventricle (lower left chamber of the heart)
B. Pacing the heart from one of two other places in the heart (the ”His” or the left bundle branch)
which are parts of the normal electrical system
- We will take a blood sample from participants after they join the study and then one year after their pacemaker is implanted.
- There will be a 3-month follow-up visit and then yearly follow-up visits (these visits are standard for patient who receive pacemakers, but we will ask participants to complete surveys that are part of the research study during these visits).
- Study participation will last until the study is over, which is expected to be five and a half years after the first participant is enrolled.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Heart Failure, AV Block, Heart Failure Heart Failure With Reduced Ejection Fraction, Intraventricular Conduction Delay, LBBB, Pacing-Induced Cardiomyopathy, RBBB
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria:
- A LVEF ≤ 50% within 6 months prior to enrollment.
- Resting QRS duration ≥130 ms as evidenced by a historical 12-lead ECG prior to enrollment OR anticipated right ventricular pacing >40% OR device in place with right ventricular pacing > 40%.
- Are optimized on HF guideline directed medical therapy according to current HF published guidelines.
Exclusion Criteria:
- Women who are pregnant, lactating, or plan to become pregnant during the course of the trial.
- Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary, intervention in the next three (3) months.
- Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment.
- Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment.
- Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis).
- Participants with Chagas disease, cardiac sarcoidosis or amyloidosis.
- Expected to receive left ventricular assist device or heart transplantation within 6 months.
- Participants with severe valvular disease (e.g., aortic stenosis).
- Have a life expectancy of less than 12 months.
- Participants with irreversible brain damage from preexisting cerebral disease.
- Participants with a contrast dye allergy unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine.
- Participants participating in any other interventional cardiovascular clinical trial.
- Participants who would be unable to return for follow-up visits due to the distance from the clinic.
- Participants who do not anticipate being a resident of the area for the scheduled duration of the trial.
