Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2016-06-30
2018-03-23
Brief Summary
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Detailed Description
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Study visit 1 will include eligibility screening, consenting process, completion of a health questionnaire and performance of a peak oxygen consumption (VO2) test. Additionally, subjects will undergo a screening lumbar MRI to ensure that there are no anatomical anomalies in or around the epidural area consistent with standard clinical practice for epidural stimulator lead placement associated with chronic pain syndromes.
Study visit 2 will include an overnight stay in the Saint Mary's Hospital Clinical Research Unit. Patients will check in to the CRU in the morning of day 1, visit 2. Prior to placement of stimulating electrodes an international normalized ratio (INR) will be checked to ensure safe clotting. An anesthesiologist will place the electrodes in the lumbar/thoracic epidural space in a manner that is standard for the clinical placement of temporary electrodes in humans. The participants will then transfer to the clinical exercise laboratory to start the exercise protocol. Participants will rest 15 minutes prior to starting exercise. Exercise will take place on a vertical bike where they will perform a submaximal cycling exercise at 30% of peak work for 29 minutes. Thigh cuffs will be placed on thigh bilaterally and inflated intermittently to pressures of 80m mmHg. After the testing is complete, participants will return to their room in the Clinical Research Unit for the rest of the day and sty over night.
On day two of visit two, participants will repeat the testing from day one with new randomization to determine reliability of testing performed on day one. After the exercise on day two of visit two, the spinal cord stimulator leads and radial arterial catheter will be removed.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Precision Spinal Cord Stimulator System
Intervention:the precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads lead extensions, each packaged as a separate kit.
Precision Spinal Cord Stimulator System
The precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads, surgical paddle leads and lead extensions, each packaged as a separate kit.
Interventions
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Precision Spinal Cord Stimulator System
The precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads, surgical paddle leads and lead extensions, each packaged as a separate kit.
Eligibility Criteria
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Inclusion Criteria
* History of ischemic or idiopathic dilated cardiomyopathy (duration \> 1yr.) stable for \> 3mo and New York Heart Association Class I-III
* Not pacemaker dependent
* Body Mass Index ≤35
* Ejection Fraction \< 40%
* Current nonsmokers with \< 15 pack year history
* Able to exercise
Exclusion Criteria
* Pregnant women
* Taking prescribed opioid medications or have had a fusion or laminectomy at L3 or above
* Patients with a recent drug-eluding stent
* History of spinal stenosis, lumbar radiculopathy, or peripheral neuropathy
* Must not currently be taking blood thinners or anticoagulant medications.
18 Years
90 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Bruce Johnson
PI
Principal Investigators
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Bruce Johnson, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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14-002521
Identifier Type: -
Identifier Source: org_study_id
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