Hypertension
Conditions
Keywords
Hypertension
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 in Europe. 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 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 unless patient has history of intolerance, ineffectiveness or contraindications.
Exclusion criteria
* Known or clinically suspected baroreflex failure or autonomic neuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | 36 months | The number of participants with serious adverse events reported in the study will be tabulated. |
Secondary
| Measure | Time frame |
|---|---|
| Systolic Office Cuff Blood Pressure (BP) | Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months |
| Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months | Baseline, 3 months, 6 months |
Countries
Germany, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MobiusHD MobiusHD
MobiusHD: Implant that is placed in the carotid sinus to control hypertension. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | MobiusHD |
|---|---|
| 24-Hour Ambulatory Blood Pressure (Systolic Blood Pressure) | 167 mmHg STANDARD_DEVIATION 16.6 |
| Age, Continuous | 52.4 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 1 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment Germany | 28 participants |
| Region of Enrollment Netherlands | 2 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
| Systolic Office Blood Pressure | 184 mmHg STANDARD_DEVIATION 18.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 18 / 30 |
| serious Total, serious adverse events | 8 / 30 |
Outcome results
Primary
Number of Participants With Serious Adverse Events (SAEs)
The number of participants with serious adverse events reported in the study will be tabulated.
Time frame: 36 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MobiusHD | Number of Participants With Serious Adverse Events (SAEs) | 8 Participants |
Secondary
Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months
Time frame: Baseline, 3 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MobiusHD | Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months | Baseline | 167 mmHg | Standard Deviation 16.6 |
| MobiusHD | Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months | 3 months | 150 mmHg | Standard Deviation 19.1 |
| MobiusHD | Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months | 6 months | 145 mmHg | Standard Deviation 19.1 |
Secondary
Systolic Office Cuff Blood Pressure (BP)
Time frame: Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MobiusHD | Systolic Office Cuff Blood Pressure (BP) | Baseline | 184 mmHg | Standard Deviation 18.4 |
| MobiusHD | Systolic Office Cuff Blood Pressure (BP) | Discharge (up to 2 days) | 147 mmHg | Standard Deviation 22.2 |
| MobiusHD | Systolic Office Cuff Blood Pressure (BP) | 7 days | 157 mmHg | Standard Deviation 27.3 |
| MobiusHD | Systolic Office Cuff Blood Pressure (BP) | 1 month | 162 mmHg | Standard Deviation 30.6 |
| MobiusHD | Systolic Office Cuff Blood Pressure (BP) | 3 months | 160 mmHg | Standard Deviation 28.4 |
| MobiusHD | Systolic Office Cuff Blood Pressure (BP) | 6 months | 160 mmHg | Standard Deviation 26.1 |