Dual Site Left Ventricular (LV) Pacing

Not Applicable

Terminated

Brief Summary: The purpose of this study is to compare Dual LV (left ventricular) pacing to standard single LV pacing (BiV pacing) to see if Dual LV pacing:

1. Improves the way the heart's left ventricle functions

2. Decreases the number of hospital and clinic visits for heart failure related symptoms

3. Slows the rate patients experience certain heart failure symptoms

4. Reduces uncoordinated heart contractions

Recruitment & Eligibility

Inclusion Criteria

Moderate or severe heart failure, defined as NYHA Class III-IV despite optimal pharmacological heart failure therapy
On heart failure medical regimen (beta blockers and ACE-I or ARB's) for at least one month before randomization
A 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a QRS duration > 120 ms
Left ventricular ejection fraction (LVEF) < 35% or equal
Willing and capable of undergoing the device implant procedure and participating in all testing associated with this clinical study
Have a life expectancy of more than 180 days, per physician discretion
Age 40 or above, ensuring of legal age to give informed consent specific to state and national law

Exclusion Criteria

Have had previous cardiac resynchronization therapy or a previous coronary venous lead
Unable to perform a Six-Minute Hall Walk (6MHW) Test
Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention)without CHB or planned AVJ ablation prior to randomization
Have an atrial tachyarrhythmia that is persistent (i.e. can be terminated with medical intervention, but does not terminate spontaneously) without planned and successful cardioversion prior to randomization (patients with unsuccessful cardioversions and no AVJ Ablation will be exited.)
Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
Have a mechanical tricuspid prosthesis
Has severe aortic or mitral stenosis
Enrolled in any concurrent study that may confound the results of this study
Patients who are or suspect they may be pregnant or plan to become pregnant

Arm && Interventions

Group	Intervention	Description
Dual Site LV Pacing	Dual Site LV Pacing	Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Dual Site LV Pacing	BiV Pacing	Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
BiV Pacing	Dual Site LV Pacing	Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
BiV Pacing	BiV Pacing	Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.

Primary Outcome Measures

Name	Time	Method
Change in Left Ventricular End Systolic Volume (LVESV)	At 6 months to one year	The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient.

Secondary Outcome Measures