Hypertension
Conditions
Keywords
Hypertension, Carotid Sinus
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.
Interventions
DEVICEMobiusHD™
Implant that is placed in the carotid sinus to control hypertension.
Sponsors
Vascular Dynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 3 years | Number of Participants with Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Office Blood Pressure (OBP) | 3 years | Change in Systolic Office Blood Pressure (OBP) compared to baseline. |
| Change in Systolic Ambulatory Blood Pressure (ABPM) | 6 months | Change in Systolic Ambulatory Blood Pressure (ABPM) measured at 3 and 6 months compared to baseline values. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MobiusHD™ MobiusHD™
MobiusHD™: Implant that is placed in the carotid sinus to control hypertension. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | MobiusHD™ |
|---|---|
| Age, Continuous | 55.4 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 17 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 9 Participants |
| Systolic Office Blood Pressure | 177 mmHg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 17 |
| other Total, other adverse events | 7 / 17 |
| serious Total, serious adverse events | 1 / 17 |
Outcome results
Primary
Adverse Events
Number of Participants with Adverse Events
Time frame: 3 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MobiusHD™ | Adverse Events | Hypotension - acute | 1 participants |
| MobiusHD™ | Adverse Events | Abnormal lab finding - hypokalemia | 1 participants |
| MobiusHD™ | Adverse Events | Access site complication - hemorrhage - groin | 1 participants |
| MobiusHD™ | Adverse Events | Access site complication - postprocedural | 1 participants |
| MobiusHD™ | Adverse Events | Anesthia complications - blurred vision | 1 participants |
| MobiusHD™ | Adverse Events | Digestive system disorder - nausea | 1 participants |
| MobiusHD™ | Adverse Events | Digestive system disorder - vomiting | 1 participants |
| MobiusHD™ | Adverse Events | Hypertension - acute | 1 participants |
| MobiusHD™ | Adverse Events | Pain - head | 1 participants |
| MobiusHD™ | Adverse Events | Pain - puncture site | 2 participants |
| MobiusHD™ | Adverse Events | Respiratory abnormalities - upper respiratory infection | 1 participants |
Secondary
Change in Systolic Ambulatory Blood Pressure (ABPM)
Change in Systolic Ambulatory Blood Pressure (ABPM) measured at 3 and 6 months compared to baseline values.
Time frame: 6 months
Population: Of the 17 subjects enrolled in the study, 16 subjects were available for for systolic ABPM measurements at 3 and 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MobiusHD™ | Change in Systolic Ambulatory Blood Pressure (ABPM) | 3 months | -11.94 mmHg | Standard Deviation 19.69 |
| MobiusHD™ | Change in Systolic Ambulatory Blood Pressure (ABPM) | 6 months | -16.00 mmHg | Standard Deviation 17.91 |
Secondary
Change in Systolic Office Blood Pressure (OBP)
Change in Systolic Office Blood Pressure (OBP) compared to baseline.
Time frame: 3 years
Population: Of the 17 subjects enrolled, 1 subject died and 1 subject withdrew from the study. The remaining 15 subjects completed all study visits through 3 years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MobiusHD™ | Change in Systolic Office Blood Pressure (OBP) | 1.5 years | -19.7 mmHg | Standard Deviation 32.5 |
| MobiusHD™ | Change in Systolic Office Blood Pressure (OBP) | 2 years | -20.3 mmHg | Standard Deviation 35.4 |
| MobiusHD™ | Change in Systolic Office Blood Pressure (OBP) | Discharge | -26.6 mmHg | Standard Deviation 18.1 |
| MobiusHD™ | Change in Systolic Office Blood Pressure (OBP) | 7 days | -19 mmHg | Standard Deviation 22.9 |
| MobiusHD™ | Change in Systolic Office Blood Pressure (OBP) | 30 days | -18.8 mmHg | Standard Deviation 20.9 |
| MobiusHD™ | Change in Systolic Office Blood Pressure (OBP) | 90 days | -23.3 mmHg | Standard Deviation 25.8 |
| MobiusHD™ | Change in Systolic Office Blood Pressure (OBP) | 180 days | -27.5 mmHg | Standard Deviation 22.6 |
| MobiusHD™ | Change in Systolic Office Blood Pressure (OBP) | 1 year | -20.8 mmHg | Standard Deviation 28.7 |
| MobiusHD™ | Change in Systolic Office Blood Pressure (OBP) | 2.5 years | -11.3 mmHg | Standard Deviation 32.4 |
| MobiusHD™ | Change in Systolic Office Blood Pressure (OBP) | 3 years | -18.2 mmHg | Standard Deviation 37.1 |