RecruitingHeart FailureHeart Failure With Reduced Ejection FractionAV Block

Left vs Left Randomized Clinical Trial

Eligible age

18+ yrs

Accepts

All genders

Locations

24 states

Healthy volunteers

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About this study

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.

Sponsor: Baylor College of Medicine

You may qualify 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 qualify 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).