Resistant Hypertension Clinical Trial
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, an estimated
12% are resistant to conventional medical intervention. Alternative effective treatments are
still needed for this hypertensive patient population to mitigate the risk and incidence of
mortality and morbidity.
This original Investigational Device Application is for a study intended to confirm the
safety and efficacy of bilateral subcutaneous median nerve stimulation using the eCoin
system to treat resistant hypertension. The eCoin device delivers electrical stimulation
pulses to the median nerve from a small coin sized device placed under the skin of the
distal anterior forearm. The implant delivers a weekly 30 minute treatment based on previous
studies showing a long lasting and cumulative effect. The safety and efficacy of eCoin
therapy has previously been demonstrated in a multinational, randomized, double-blind,
sham-controlled study in New Zealand, Taiwan and Canada.
This trial is a multi-center, prospective, double-blind, 1:1 randomized sham-controlled
study of the safety and effectiveness of eCoin median nerve neuromodulation in subjects with
drug-treatment resistant hypertension. The eCoin neuromodulation device will be implanted
subcutaneously in the right and left forearms of patients with uncontrolled hypertension
despite treatment with 3 or more antihypertensive agents. After a 4 week implant healing
period, subjects will be 1:1 randomized into either a treatment or control group. One half
of the subjects have their devices activated (treatment) and the other half undergo a sham
activation (control) to maintain participant blinding to their treatment allocation. During
the six months post-randomization, the eCoin is ON in the treatment group and OFF in the
control group.
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