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Spinal Cord Stimulation
Spinal Stimulation for Heart Failure
N/A
Waitlist Available
Led By Bruce Johnson, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current nonsmokers with < 15 pack year history
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days
Awards & highlights
Study Summary
This trialplans to see if epidural stimulation can help Heart Failure patients exercise w/ better heart control.
Who is the study for?
This trial is for heart failure patients who are not pacemaker dependent, have a BMI ≤35, an Ejection Fraction <40%, and can exercise. They should be current nonsmokers with a limited smoking history, stable in their condition for over 3 months, and classified as NYHA Class I-III. Those with severe cardiopulmonary issues, recent stents or surgeries on the spine, pregnant women, opioid users or blood thinner users cannot join.Check my eligibility
What is being tested?
The study tests if the Precision Spinal Cord Stimulator System can help control cardiovascular function during exercise in heart failure patients. It aims to see whether this spinal stimulation could benefit those with reduced ejection fraction due to ischemic or idiopathic dilated cardiomyopathy.See study design
What are the potential side effects?
While specific side effects are not listed here, spinal cord stimulators may generally cause discomfort at the implant site, unwanted changes in stimulation related to movements or posture adjustments and potential nerve damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I currently do not smoke and have smoked less than 15 pack-years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Arterial Pressure
Trial Design
1Treatment groups
Experimental Treatment
Group I: Precision Spinal Cord Stimulator SystemExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,043 Total Patients Enrolled
72 Trials studying Heart Failure
1,021,988 Patients Enrolled for Heart Failure
Bruce Johnson, PhDPrincipal Investigator - Mayo Clinic
Broome Obstetrics and Gynecology PC, Good Shepherd Rehabilitation at Pocono Medical Center, Pocono Medical Center
2 Previous Clinical Trials
147 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's pumping ability is less than 40%.I currently do not smoke and have smoked less than 15 pack-years.I am on prescribed opioids or had spine surgery at L3 or higher.You have recently had a stent placed that releases medication.I have had spinal stenosis, lumbar radiculopathy, or peripheral neuropathy.I am not currently on blood thinners or anticoagulant medications.I have heart failure with a history of heart muscle issues, stable for over 3 months.You do not rely on a pacemaker to regulate your heart.I have heart or lung conditions and serious irregular heartbeats.You have a body mass index (BMI) of 35 or less.You are able to do physical activity.
Research Study Groups:
This trial has the following groups:- Group 1: Precision Spinal Cord Stimulator System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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