Left vs Left RCT
Brief description of study
This study aims to 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. This is for patients with heart failure who are already receiving current standard heart failure pharmacological therapy.
Detailed description of study
This is a multisite study in the US and Canada with a total of about 2,136 participants, and will last over a period of about five and a half years from the enrollment of the first participant. It is for participants with a weak heart (heart failure). Participants will be randomly assigned to one of two treatments (A or B), both of which are standard of care heart pacing treatments.
- Pacing the heart from two locations in the left ventricle
- Pacing the heart from one of two other placing in the heart, which are parts of the normal electrical system
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: 99 years or below
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Gender: All
Inclusion
A LVEF ≤ 50% within 6 months prior to enrollment.
Resting QRS duration ≥130 ms OR anticipated right ventricular pacing >40% OR device in place with right ventricular pacing > 40%.
Are optimized on HF guideline directed medical therapy
Exclusion
People who are pregnant
Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment.
Expected to receive left ventricular assist device or heart transplantation within 6 months.
Participants with a contrast dye allergy unable or unwilling to undergo pretreatment
Participants participating in any other interventional cardiovascular clinical trial.
