Clinical Trials Logo
  1. Home
  2. Resistant Hypertension
  3. NCT02926495

Subcutaneous Median Nerve Neuromodulation For Drug-Treatment Resistant Hypertension.

Resistant Hypertension Clinical Trial

Clinical Trial 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, 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02926495
Study type Interventional
Source Valencia Technologies Corporation
Contact
Status Withdrawn
Phase N/A
Start date November 2016
Completion date December 2018
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05545059 - Effects and Safety of Sacubitril/Valsartan on Refractory Hypertension Phase 3
Not yet recruiting NCT04388124 - VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH RESISTANT ARTERIAL HYPERTENSION Phase 2
Withdrawn NCT01939392 - Rapid Renal Sympathetic Denervation for Resistant Hypertension II Phase 2/Phase 3
Recruiting NCT06228677 - Comparison of Catecholamine Concentrations in Venous Blood During Selective Adrenal Artery Embolization
Recruiting NCT04213963 - Prospective Study on Primary Aldosteronism in Resistant Hypertension
Recruiting NCT05563077 - Aerobic Exercise and Resistant Hypertension N/A
Recruiting NCT03758196 - Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension（RSDARH） N/A
Active, not recruiting NCT03179800 - CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™ N/A
Completed NCT04519658 - A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN) Phase 2
Not yet recruiting NCT05426707 - Remote Ischemic Conditioning for the Treatment of Resistant Hypertension N/A
Not yet recruiting NCT05552300 - Superselective Adrenal Arterial Embolization for Resistant Hypertension N/A
Completed NCT04345198 - Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension N/A
Active, not recruiting NCT05562934 - An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients. Phase 2
Recruiting NCT06034743 - A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension Phase 3
Active, not recruiting NCT02670681 - Effects of Aerobic Exercise on Blood Pressure Levels of Resistant Hypertensive Subjects N/A
Completed NCT02572024 - The Effect of BATon BP and Sympathetic Function in Resistant Hypertension (The Nordic BAT Study) N/A
Terminated NCT02295683 - Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - Iberis-HTN Registry
Completed NCT02001350 - Carotid Ultrasound Study N/A
Recruiting NCT04331691 - Comparison of Spironolactone and Amiloride on Home Blood Pressure in Resistant Hypertension Phase 4
Recruiting NCT04637152 - Sacubitril/Valsartan in Resistant Hypertension Phase 2