Left vs Left Randomized Clinical Trial

Launched by BAYLOR COLLEGE OF MEDICINE · Dec 6, 2022

Keywords

ClinConnect Summary

The Left vs Left Randomized Clinical Trial is studying two types of heart pacing techniques—His pacing and Left bundle branch pacing—to see how they compare to the standard method called biventricular pacing. The goal is to find out which method helps improve patients' quality of life, physical activity, and overall heart health, while also looking at safety concerns like device-related complications. This study is specifically for adults aged 18 and older who have heart failure with a weakened heart (specifically, a condition where the heart's pumping ability is less than 50%) and certain heart rhythm issues.

To participate in this trial, individuals must be on appropriate heart failure medications and meet certain health criteria, such as having a specific heart measurement (called QRS duration) from a recent ECG. However, some people won't be eligible, including those with severe heart conditions that might require surgery soon or those with certain heart diseases. If someone decides to join, they can expect to be monitored closely throughout the study for any changes in their health and how they feel. This research could potentially lead to better treatments for heart failure patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• 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 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.