An interventional study of MobiusHD™ in Hypertension, sponsored by Vascular Dynamics, Inc.. Completed at 7 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Vascular Dynamics, Inc. · Not applicable, Interventional, and Treatment
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 17 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Vascular Dynamics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MobiusHD™
Device: MobiusHD™
Implant that is placed in the carotid sinus to control hypertension.
Adverse Events
Number of Participants with Adverse Events
Time frame: 3 years
Change in Systolic Office Blood Pressure (OBP)
Change in Systolic Office Blood Pressure (OBP) compared to baseline.
Time frame: 3 years
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
| Milestone | MobiusHD™ |
|---|---|
| Started | 17 |
| Completed | 15 |
| Not completed | 2 |
Number of Participants with Adverse Events
| participants | MobiusHD™ |
|---|---|
| Hypotension - acute | 1 |
| Abnormal lab finding - hypokalemia | 1 |
| Access site complication - hemorrhage - groin | 1 |
| Access site complication - postprocedural | 1 |
| Anesthia complications - blurred vision | 1 |
| Digestive system disorder - nausea | 1 |
| Digestive system disorder - vomiting | 1 |
| Hypertension - acute | 1 |
| Pain - head | 1 |
| Pain - puncture site | 2 |
| Respiratory abnormalities - upper respiratory infection | 1 |
Change in Systolic Office Blood Pressure (OBP) compared to baseline.
| mmHg | MobiusHD™ |
|---|---|
| Discharge | -26.6 ± 18.1 |
| 7 days | -19 ± 22.9 |
| 30 days | -18.8 ± 20.9 |
| 90 days | -23.3 ± 25.8 |
| 180 days | -27.5 ± 22.6 |
| 1 year | -20.8 ± 28.7 |
| 1.5 years | -19.7 ± 32.5 |
| 2 years | -20.3 ± 35.4 |
| 2.5 years | -11.3 ± 32.4 |
| 3 years | -18.2 ± 37.1 |
Change in Systolic Ambulatory Blood Pressure (ABPM) measured at 3 and 6 months compared to baseline values.
| mmHg | MobiusHD™ |
|---|---|
| 3 months | -11.94 ± 19.69 |
| 6 months | -16.00 ± 17.91 |
Collected over Adverse event data were collected through study completion (3 years).. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MobiusHD™ | 1/17 (5.9%) | 1/17 (5.9%) | 7/17 (41.2%) |
| Event | MobiusHD™ |
|---|---|
| Hypotension - acuteGeneral disorders | 1/17 |
| Event | MobiusHD™ |
|---|---|
| Pain - puncture siteSkin and subcutaneous tissue disorders | 2/17 |
| Abnormal lab finding - hypokalemiaBlood and lymphatic system disorders | 1/17 |
| Access site complication - hemorrhage - groinSkin and subcutaneous tissue disorders | 1/17 |
| Access site complications - postproceduralSkin and subcutaneous tissue disorders | 1/17 |
| Anesthesia complications - blurred visionEye disorders | 1/17 |
| Arrhythmia - BradycardiaCardiac disorders | 1/17 |
| Digestive system disorder - nauseaGastrointestinal disorders | 1/17 |
| Digestive system disorder - vomittingGastrointestinal disorders | 1/17 |
| Hypertension - acuteCardiac disorders | 1/17 |
| Pain - headGeneral disorders | 1/17 |
| Age, Continuous(years) | MobiusHD™ |
|---|---|
| Mean | 55.4 (30 to 75) |
| Sex: Female, Male(Participants) | MobiusHD™ |
|---|---|
| Female | 8 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | MobiusHD™ |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | MobiusHD™ |
|---|---|
| United States | 17 |
| Systolic Office Blood Pressure(mmHg) | MobiusHD™ |
|---|---|
| Mean | 177 (160 to 203) |
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Vascular Dynamics, Inc.