Study Results
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View full resultsBasic Information
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TERMINATED
NA
50 participants
INTERVENTIONAL
2009-06-30
2013-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
BiV Pacing
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
BiV 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
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
BiV Pacing
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
Interventions
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Dual Site LV Pacing
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
BiV Pacing
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Imran K Niazi, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Aurora Cardiovascular Services
Lake Geneva, Wisconsin, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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L-08-166
Identifier Type: -
Identifier Source: org_study_id
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