None listed
Conditions
Brief summary
Hypertension is a serious public health issue, affecting approximately 30% of adults. Hypertension greatly contributes to the risk for heart disease and stroke, both among the top three leading causes of death in the Americas, Europe, and Asia. While most treated individuals with hypertension are controlled on medication, diet and exercise, at least an estimated 12% are resistant to conventional medical intervention. This study will examine the safety and efficacy of a chronic therapeutic device that is meant to reduce hypertension in patients with uncontrolled hypertension.
Interventions
Arm 1 (Treatment Arm): Implanted with Subcutaneous Neuromodulation System (SNS) and fitted within 2 weeks of implantation. The bilateral implantation procedure is done under local anesthesia in an outpatient setting. Each device takes approximately 10 to 15 minutes per arm.
SNS therapy for hypertension provides electrical stimulation to the median nerve from a small self-contained implant placed in the subcutaneous space over the median nerve in the forearm. Subjects receive bilateral implant
Arm 1 (Treatment Arm): Implanted with Subcutaneous Neuromodulation System (SNS) and fitted within 2 weeks of implantation. The bilateral implantation procedure is done under local anesthesia in an outpatient setting. Each device takes approximately 10 to 15 minutes per arm. SNS therapy for hypertension provides electrical stimulation to the median nerve from a small self-contained implant placed in the subcutaneous space over the median nerve in the forearm. Subjects receive bilateral implants in a simple procedure under local anesthetic. The implant is programmed in manufacturing to provide once weekly 30 minute stimulation sessions. In between sessions, the implant is dormant. The implant is set in manufacturing to provide low rate stimulation. Amplitude is settable with a programming controller, and is ramped up to the highest comfortable level for the subject during a fitting session that lasts approximately 45 minutes which includes the initial 30 minute therapy session. The device contains a battery that will operate for approximately2-3 years, before the device requires replacement. Next generation systems are expected to last 5 years.
Sponsors
Valencia Technologies, Corp.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Individual has a systolic blood pressure measured at greater than or equal to 140mmHg in the most recent medical history and which is confirmed with in-office blood pressure measured at both an initial screening and baseline screening visit and also with a 24 hour Ambulatory blood pressure, despite adhering to a stable anti-hypertensive drug regimen for a minimum of two weeks prior to enrollment of three or more anti- hypertensive medications including a diuretic OR 2. Individual has a systolic blood pressure measured at greater than or equal to 160mmHg in the most recent medical history and which is confirmed with in-office blood pressure measured at both an initial screening and baseline screening visit and also with a 24 hour Ambulatory blood pressure, despite adhering to a stable anti-hypertensive drug regimen for a minimum of two weeks prior to enrollment of two or more anti- hypertensive medications and has documented allergy to or intolerance of additional antihypertensive medications.
Exclusion criteria
1. Individual in whom medications are expected to change during the next 12 months 2. Individual does not agree to have all study procedures performed, and is not competent and willing to provide written, informed consent to participate in this clinical study. 3. Individual has type 1 diabetes mellitus. 4. Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six months of the screening visit. 5. Individual has a scheduled or planned surgery, cardiovascular intervention, or dialysis in the next six months. 6. Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous. 7. Individual has any serious medical condition with a prognosis of <2 years. 8. Individual has significant anemia (hemoglobin <100g/L), thrombocytopenia (platelets <100x109/L) or a severe bleeding disorder eg. hemophilia. 9. Individual has secondary hypertension (other than associated with obstructive sleep apnea) 10. Individual is pregnant, nursing or planning to be pregnant. 11. Individual has known or suspected history of medication non-compliance 12. Individual has known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements. 13. Patient has undergone renal denervation. 14. Individual has severe renal dysfunction (CKD V, eGFR <15) 15. Individual has another implantable stimulation device including a cardiac pacemaker, ICD, spinal cord stimulator, brain stimulator, vagus nerve stimulator, peripheral nerve stimulator, or cochlear implant. 16. Patient is scheduled to have an MRI. 17. Individual is currently enrolled in another investigational drug or device trial that has not reached its primary endpoint.
Outcome results
None listed