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The goal of this interventional study is to evaluate the safety and preliminary effectiveness of the ARC-IM Therapy to improve hemodynamic management in people with sub-acute or chronic spinal cord injury.
Participants will be implanted with the ARC-IM Thoracic System which aim to deliver, at the low thoracic level, targeted epidural electrical stimulation that will support natural hemodynamic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | All participants will be provided with the ARC-IM Thoracic System (implantable and non-implantable parts) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARC-IM Thoracic System implantation | Device | Implantation of the ARC-IM Thoracic Lead on the low thoracic level of the spinal cord and implantation of the ARC-IM IPG in the abdominal region |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of Serious Adverse Event and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM Thoracic System | Assess the safety of ARC-IM Therapy at supporting the management of hemodynamic instability with sub-acute or chronic spinal cord injury suffering from orthostatic hypotension | Throughout study, average of 15.5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilse Van Nes, MD, PhD | Sint Maartenskliniek, department of rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sint Maartenskliniek | Recruiting | Ubbergen | 6574NA | Netherlands |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D007024 | Hypotension, Orthostatic |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| D014947 | Wounds and Injuries |
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |