Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure

Novel Pacing Modality to Initiate Favorable Cardiac Remodeling in Heart Disease

This project utilizes a novel cardiac pacing approach hypothesized to initiate beneficial cardiac conditioning and remodeling over a period of time.

The project studies subjects with non-ischemic cardiomyopathy who have a pacing device already implanted. Subjects randomized to the pacing intervention versus a sham intervention will be compared for various symptomatic, functional and other outcomes. Each subject will undergo baseline quality of life/symptom questionnaires and clinical testing for cardiac functional/structural effects and exercise tolerance, then the intervention vs. sham (subjects blinded to their category), followed by repeat questionnaires and clinical testing. Medical record review will be undertaken to establish demographic variables, baseline and follow up testing results.

Inclusion Criteria:

• Non-Ischemic Cardiomyopathy
• Ejection Fraction </= 35% despite at least 3 months stable standard medical management
• New York Heart Association Class II-III symptoms
• Dual chamber implantable cardioverter defibrillator in place or Biventricular ICD in place (over 3 months old)
• Normal Atrioventricular conduction or Biventricular ICD
• QRS < 120 msec (inherent conduction or paced with BiV ICD)

Exclusion criteria:

• Age < 18 years
• Inability to ambulate safely
• Congenital or primary valve disease
• Left Ventricular thrombus
• Severe peripheral arterial disease
• Admission for life-threatening condition (eg heart failure, stroke) in the past 3 months
• Major surgery in the past 3 months or anticipated during the period of the trial
• Paced or intrinsic QRS >120 msec
• Life expectancy < 1 year
• Hemodialysis
• Hematocrit < 30%
• Severe Chronic lung disease
• Pregnancy
• ICD battery longevity < 1 year
• Unsuppressed atrial arrhythmias
• Already participating in an exercise programusion Criteria