Status:
TERMINATED
Dual Site Left Ventricular (LV) Pacing
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Medtronic
Conditions:
Congestive Heart Failure
LV Dysfunction
Eligibility:
All Genders
40+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00944125
Start Date
June 1 2009
End Date
July 1 2013
Last Update
October 21 2024
Active Locations (2)
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1
Aurora Cardiovascular Services
Lake Geneva, Wisconsin, United States, 53147
2
Aurora Cardiovascular Services
Milwaukee, Wisconsin, United States, 53215