Study Stopped
Lack of funding to continue the study
Spinal Stimulation During Exercise in Heart Failure
Spinal Cord Stimulation to Inhibit Afferent Feedback During Exercise in Heart Failure
1 other identifier
interventional
7
1 country
1
Brief Summary
The purpose of this proposal is to determine whether epidural spinal cord stimulation can modulate cardiovascular control during exercise in Heart Failure patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2016
CompletedFirst Posted
Study publicly available on registry
January 20, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2018
CompletedResults Posted
Study results publicly available
May 22, 2024
CompletedMay 22, 2024
April 1, 2024
1.8 years
January 11, 2016
April 25, 2024
April 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Arterial Pressure
This will allow for continuous real-time intra-arterial measurement of beat-to-beat blood pressure.
2 days
Study Arms (1)
Precision Spinal Cord Stimulator System
EXPERIMENTALIntervention: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.
Interventions
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
You may qualify if:
- Heart Failure patients with reduced ejection fraction:
- 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
You may not qualify if:
- History of cardiopulmonary disorders and dangerous arrhythmias
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Bruce Johnson
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce Johnson, PhD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
January 11, 2016
First Posted
January 20, 2016
Study Start
June 1, 2016
Primary Completion
March 23, 2018
Study Completion
March 23, 2018
Last Updated
May 22, 2024
Results First Posted
May 22, 2024
Record last verified: 2024-04