Dual Site LV Pacing Study: Prospective Randomized Blinded Crossover Study of Patients Meeting Current CRT-D Indication to be Implanted With Dual LV Pacing Leads and Paced Chronically for at Least 6 Months Post-implant.

Wake Forest University Health Sciences1 site in 1 country50 target enrollmentJune 2009

ConditionsCongestive Heart Failure LV Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Congestive Heart Failure
Sponsor: Wake Forest University Health Sciences
Enrollment: 50
Locations: 1
Primary Endpoint: Change in Left Ventricular End Systolic Volume (LVESV)
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

Improves the way the heart's left ventricle functions
Decreases the number of hospital and clinic visits for heart failure related symptoms
Slows the rate patients experience certain heart failure symptoms
Reduces uncoordinated heart contractions

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

July 2013

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Wake Forest University Health Sciences

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Left Ventricular End Systolic Volume (LVESV)

Time Frame: 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.