CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vascular Dynamics, Inc.
- Enrollment
- 17
- Locations
- 7
- Primary Endpoint
- Adverse Events
Study Overview
Brief Summary
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
Detailed Description
This is an open-label, multicenter, first-in-man clinical trial to be conducted inside the United States. Eligible subjects with stage 2 resistant systemic arterial hypertension currently being treated with a minimum of three (3) anti-hypertensive drugs, who consent to study participation will be assigned to treatment with the MobiusHD system.
Potential study participants will be consented and then screened at two (2) baseline visits beginning at least 30 days prior to MobiusHD placement. Qualified patients will undergo placement of the MobiusHD under angiographic visualization, and will then be followed for 36 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Office cuff SBP ≥ 160 mmHg measured per protocol instructions (Appendix IV) following at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic. Any combination medications will be counted per the active ingredient. (For example, Zestoretic (Lisinopril +HCTZ) equals two (2) anti-hypertensive medications)
Exclusion Criteria
- •Known or clinically suspected baroreflex failure or autonomic neuropathy
Arms & Interventions
MobiusHD™
MobiusHD™
Intervention: MobiusHD™ (Device)
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 3 years
Number of Participants with Adverse Events
Secondary Outcomes
- Change in Systolic Office Blood Pressure (OBP)(3 years)
- Change in Systolic Ambulatory Blood Pressure (ABPM)(6 months)