HIS-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy (HOT-CRT)
Heart Failure,Congestive, Cardiomyopathies, Left Ventricular Dysfunction
About this trial
This is an interventional treatment trial for Heart Failure,Congestive focused on measuring Heart Failure, Cardiac Resynchronization Therapy
Eligibility Criteria
Inclusion Criteria:
- Patients at least 18 years of age
Diagnosis is NYHA Class II, III, and ambulatory Class IV heart failure with either ischemic or nonischemic cardiomyopathy and patients with NYHA Class I symptoms and ischemic cardiomyopathy, with at least one of the following:
- LV systolic dysfunction with LVEF ≤ 35% and Evidence of bundle branch block with QRS duration > 120 msec
- LV systolic dysfunction with LVEF ≤ 50% and with need for >40% Right Ventricular (RV) pacing
Exclusion Criteria:
- Existing CRT device
- Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
- Pregnancy
- Participation in other device trials
- Inability to complete study requirements
Sites / Locations
- Geisinger Health
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
HOT-CRT
Biventricular Pacing
Subjects randomized to HOT-CRT will undergo CRT as described below. His bundle pacing lead will be placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and LV timing may be optimized to achieve maximal resynchronization. This will be at the discretion of the implanting physician. Only FDA approved leads and devices will be used.
Subjects randomized to biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.Only FDA approved leads and devices will be used.