Left vs Left Randomized Clinical Trial

What this study is about

The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated \>40% pacing who are already receiving current standard heart failure pharmacological therapy.

Who can join (things the study team will check)

✅ You may be able to join if…

• Men and women 18 years of age or older.
• 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 OR patient's physician will make an effort to start all guideline-directed medical therapy and titrate doses up as permitted by the participant clinical status and co-morbidities prior to implantation procedure.

🚫 You may not be able to join if…

• 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 primary 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 comply with the study's follow-up visit schedule; or
• Participants who had any prior unsuccessful attempt at implantation of biventricular pacing (BiVP), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP) device.

Where this trial is running

• Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ, Gilbert, Arizona, United States
• University of Arizona College of Medicine- Phoenix, Tucson, Arizona, United States
• University of Arkansas for Medical Sciences (UAMS), Little Rock, Arkansas, United States
• University of California San Diego, La Jolla, California, United States
• University of Colorado (Anschutz Medical Campus), Denver, Colorado, United States
• South Denver Cardiology Associates, Littleton, Colorado, United States
• Hartford Hospital, Hartford, Connecticut, United States
• Yale University, New Haven, Connecticut, United States
• Heart Rhythm Solutions, Davie, Florida, United States
• University of Florida Jacksonville, Jacksonville, Florida, United States
• Mount Sinai Medical Center of Florida, Inc., Miami Beach, Florida, United States
• Cleveland Clinic Florida, Palm Beach Gardens, Florida, United States

+ 59 more sites.

Who to contact

Mihail G Chelu, MD, PhD · 7137987291 · leftvsleft@bcm.edu

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05650658.