Clinical Trial Title
Cardiac resynchronization therapy using His/Left bundle pacing vs left ventricular epicardial pacing in patients with heart failure with LVEF <50% and a wide QRS complex (>130 ms) or with/anticipated >40% pacingNational Clinical Trial Number:
NCT05650658Contact Information
Clinical Trial Protocol Description:
The objective of this study is to assess the comparative effectiveness of His/LBBP concerning patient-centered outcomes, including quality of life (QoL), physical activity, heart failure (HF) hospitalization, and mortality. Additionally, the study aims to evaluate the comparative safety of His/LBBP in terms of device-related complications and re-interventions (such as lead dislodgement and infection) compared to the standard of care Biventricular Pacing (BiVP).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have a LVEF ≤ 50% within 6 months prior to enrollment.
- Have 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.
You will be excluded from the study if any of the following criteria apply to you:
- Are pregnant, lactating, or plan to become pregnant during the course of the trial.
- Have had coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment.
- Have Chagas disease, cardiac sarcoidosis, or amyloidosis.
- Are expected to receive left ventricular assist device or heart transplantation within 6 months.
- Have severe valvular disease (e.g., aortic stenosis).
- Have a life expectancy of less than 12 months.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.