ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
ONWARD Medical, Inc.
Summary
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Aged 18 years or above, and no older than 75 years at the time of enrollment. 2. 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. 3. 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. 4. Evidence of symptomat…
Interventions
- ProcedureARC-IM System Implantation
Implantation of the ARC-IM Thoracic Lead in the epidural space and ARC-IM Neurostimulator
- DeviceARC-IM Therapy (Group 1)
The 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
- DeviceARC-IM Therapy (Group 2)
The 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
Locations (12)
- University of Arkansas for medical SciencesLittle Rock, Arkansas
- Craig HospitalEnglewood, Colorado
- University of MiamiMiami, Florida
- Shepherd Center / Emory UniversityAtlanta, Georgia
- UofL Health - Frazier Rehabilitation InstituteLouisville, Kentucky
- VA LouisvilleLouisville, Kentucky