Dual Site Left Ventricular (LV) Pacing

Stopped early · Not applicable

Conditions studied: Congestive Heart Failure, LV Dysfunction

In brief

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

Key facts

Study ID: NCT00944125
Run by: Wake Forest University Health Sciences
People needed: 50
Starts: 2009-06-01
Expected to finish: 2013-07-01
Last updated by the study team: 2024-10-21

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Aurora Cardiovascular Services — Lake Geneva, Wisconsin, United States
Aurora Cardiovascular Services — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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