ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorONWARD Medical, Inc.
About this trial
Empower BP is a pivotal, interventional, multicenter, prospective, randomized, controlled double-blinded study to evaluate the safety and effectiveness of the ARC-IM System in managing symptomatic blood pressure instability in individuals with chronic SCI (\>1 year after SCI).
The primary effectiveness outcome will be evaluated through subject-reported ADFSCI and seated blood pressure assessments at 3 months post-implant.
Following a baseline screening period and the surgical implantation of the ARC-IM System, subjects will be randomized with a 2:1 ratio into an active or control arm for 3 months. All the subjects will undergo therapy activation sessions (into either Group 1: active intervention, or Group 2: intervention aimed to mimic the active intervention without the active component) within 21 days of the surgical implant and will then commence independent at-home use of ARC-IM Therapy. At the 3 Month timepoint, after all assessments are conducted, all subjects will transition to the open-label period in order to receive the active version of the ARC-IM System in an open-label fashion. All subjects will undergo therapy programming sessions following Month 3.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or above, and no older than 75 years at the time of enrollment.
Clinical evidence of Orthostatic Hypotension (blood pressure drop of 20mmHg systolic or 10mmHg diastolic) measured during Head Up Tilt Table assessment (HUTT, within 10 minutes) with current standard of care if any. 2 out of 3 tests must meet OH criteria.
Clinical evidence of sustained hypotension (average systolic Blood pressure ≤ 110 mmHg) when measured each minute for 10 minutes while seated and in the absence of supportive compressive garments and medication.
Evidence of symptomatic hypotension as determined by a non-zero OHSA total score
Disqualifiers
Subject has an autoimmune etiology of spinal cord dysfunction/injury.
Subject has diseases and conditions that would increase the morbidity and mortality of the surgical procedures required by the study.
Subject has a history of physiologic hypotension prior to SCI
Subject has a history of unexpected blood pressure instability related to medications
Trial design
Design model
Crossover
Treatments tested in this trial
ARC-IM System Implantation
Procedure/SurgeryImplantation of the ARC-IM Thoracic Lead in the epidural space and ARC-IM Neurostimulator
ARC-IM Therapy (Group 1)
DeviceThe ARC-IM System is programmed since day 0 to deliver active electrical spinal cord stimulation at the low thoracic level for the management of symptomatic blood pressure instability in people with chronic spinal cord injury
ARC-IM Therapy (Group 2)
DeviceThe ARC-IM System is programmed at month 3 to deliver active electrical spinal cord stimulation at the low thoracic level for the management of symptomatic blood pressure instability in people with chronic spinal cord injury
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group 1Experimental treatment 2 interventions
Group B: Group 2Sham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of subjects achieving a change in the hypotension domain of the ADFSCI short-form questionnaire
Proportion of subjects achieving a reduction of ≥ 4 points in the hypotension domain of the ADFSCI short-form questionnaire compared to baseline
Time frame
3-months post-implant2
Proportion of subjects achieving elevation in SBP during seated BP test
Proportion of subjects achieving an elevation of ≥ 10 mmHg in systolic blood pressure during the seated BP test with stimulation ON compared to stimulation OFF
Time frame
3-months post-implant3
Incidence of serious adverse device effects
Description of all Serious Adverse Device Effects from ARC-IM System implant until Month 6
Time frame
6-months post-implantSponsors and contacts
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Source ClinicalTrials.gov