This clinical study has been designed to test whether a new pacing therapy would lead to
improvement in heart function, symptoms and quality of life in a specific group of heart
failure patients. This group has a unique electrical conduction problem (Right Bundle Branch
Block) that did not respond well to the current available pacing therapy.
This pilot clinical trial will be a randomized single blinded cross over trial. Each subject
will undergo three study stages. Subject will be randomized initially to either of the two
arms; experimental or placebo, and then will be followed up for 3 months for the first stage
to assess outcomes. In the second stage, both arms transition to a two months, intervention
free, wash out period. Finally, at the third stage both arms will cross over and subject
will be followed up for an additional 3 months for outcomes assessment.
- Cardiomyopathy; ischemic or non-ischemic on optimal medical therapy per current heart
failure treatment guidelines for at least 3 months.
- LVEF < 35% by trans-thoracic echocardiogram assessment
- Prior implantation of pacemaker/defibrillator with at least an atrial and RV mid
septal lead. Atrial lead can be waived if RV lead has atrial sensing capabilities*
- Normal sinus rhythm at enrollment
- RBBB with QRS duration >120 msec on 12 lead surface EKG.
- PR interval <250 msec on 12 lead surface EKG
- Subjects with biventricular pacemaker/ICD will be eligible for enrollment if
their LV lead pacing function has been turned off by the subject's primary
cardiologist prior to study enrollment for at least 3 months (this could be due
to lead malfunction or the decision to deactivate the LV pacing therapy for any
reason per primary cardiologist discretion)
- Age younger than 18 years old
- Acute Myocardial infarction within 6 months of entry into the study
- Inotrope dependent heart failure condition
- Left ventricular assist device or heart transplantation
- Any other known conditions other than heart failure that could limit survival to < 6
- Atrial fibrillation or flutter burden >10% of the time within the last 6 months
- Atrioventricular node disease that requires ventricular pacemaker support >10% of the