Trial Outcomes & Findings for Controlling and Lowering Blood Pressure With The MOBIUSHD™ (NCT NCT01831895)
NCT ID: NCT01831895
Last Updated: 2023-05-06
Results Overview
Number of Participants with Adverse Events
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
3 years
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
MobiusHD™
MobiusHD™
MobiusHD™: Implant that is placed in the carotid sinus to control hypertension.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Controlling and Lowering Blood Pressure With The MOBIUSHD™
Baseline characteristics by cohort
| Measure |
MobiusHD™
n=17 Participants
MobiusHD™
MobiusHD™: Implant that is placed in the carotid sinus to control hypertension.
|
|---|---|
|
Age, Continuous
|
55.4 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=99 Participants
|
|
Systolic Office Blood Pressure
|
177 mmHg
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 yearsNumber of Participants with Adverse Events
Outcome measures
| Measure |
MobiusHD™
n=17 Participants
MobiusHD™
MobiusHD™: Implant that is placed in the carotid sinus to control hypertension.
|
|---|---|
|
Adverse Events
Hypotension - acute
|
1 participants
|
|
Adverse Events
Abnormal lab finding - hypokalemia
|
1 participants
|
|
Adverse Events
Access site complication - hemorrhage - groin
|
1 participants
|
|
Adverse Events
Access site complication - postprocedural
|
1 participants
|
|
Adverse Events
Anesthia complications - blurred vision
|
1 participants
|
|
Adverse Events
Digestive system disorder - nausea
|
1 participants
|
|
Adverse Events
Digestive system disorder - vomiting
|
1 participants
|
|
Adverse Events
Hypertension - acute
|
1 participants
|
|
Adverse Events
Pain - head
|
1 participants
|
|
Adverse Events
Pain - puncture site
|
2 participants
|
|
Adverse Events
Respiratory abnormalities - upper respiratory infection
|
1 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: 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.
Change in Systolic Office Blood Pressure (OBP) compared to baseline.
Outcome measures
| Measure |
MobiusHD™
n=17 Participants
MobiusHD™
MobiusHD™: Implant that is placed in the carotid sinus to control hypertension.
|
|---|---|
|
Change in Systolic Office Blood Pressure (OBP)
Discharge
|
-26.6 mmHg
Standard Deviation 18.1
|
|
Change in Systolic Office Blood Pressure (OBP)
7 days
|
-19 mmHg
Standard Deviation 22.9
|
|
Change in Systolic Office Blood Pressure (OBP)
30 days
|
-18.8 mmHg
Standard Deviation 20.9
|
|
Change in Systolic Office Blood Pressure (OBP)
90 days
|
-23.3 mmHg
Standard Deviation 25.8
|
|
Change in Systolic Office Blood Pressure (OBP)
180 days
|
-27.5 mmHg
Standard Deviation 22.6
|
|
Change in Systolic Office Blood Pressure (OBP)
1 year
|
-20.8 mmHg
Standard Deviation 28.7
|
|
Change in Systolic Office Blood Pressure (OBP)
1.5 years
|
-19.7 mmHg
Standard Deviation 32.5
|
|
Change in Systolic Office Blood Pressure (OBP)
2 years
|
-20.3 mmHg
Standard Deviation 35.4
|
|
Change in Systolic Office Blood Pressure (OBP)
2.5 years
|
-11.3 mmHg
Standard Deviation 32.4
|
|
Change in Systolic Office Blood Pressure (OBP)
3 years
|
-18.2 mmHg
Standard Deviation 37.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 17 subjects enrolled in the study, 16 subjects were available for for systolic ABPM measurements at 3 and 6 months.
Change in Systolic Ambulatory Blood Pressure (ABPM) measured at 3 and 6 months compared to baseline values.
Outcome measures
| Measure |
MobiusHD™
n=16 Participants
MobiusHD™
MobiusHD™: Implant that is placed in the carotid sinus to control hypertension.
|
|---|---|
|
Change in Systolic Ambulatory Blood Pressure (ABPM)
3 months
|
-11.94 mmHg
Standard Deviation 19.69
|
|
Change in Systolic Ambulatory Blood Pressure (ABPM)
6 months
|
-16.00 mmHg
Standard Deviation 17.91
|
Adverse Events
MobiusHD™
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MobiusHD™
n=17 participants at risk
MobiusHD™
MobiusHD™: Implant that is placed in the carotid sinus to control hypertension.
|
|---|---|
|
General disorders
Hypotension - acute
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected through study completion (3 years).
|
Other adverse events
| Measure |
MobiusHD™
n=17 participants at risk
MobiusHD™
MobiusHD™: Implant that is placed in the carotid sinus to control hypertension.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Pain - puncture site
|
11.8%
2/17 • Number of events 2 • Adverse event data were collected through study completion (3 years).
|
|
Blood and lymphatic system disorders
Abnormal lab finding - hypokalemia
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected through study completion (3 years).
|
|
Skin and subcutaneous tissue disorders
Access site complication - hemorrhage - groin
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected through study completion (3 years).
|
|
Skin and subcutaneous tissue disorders
Access site complications - postprocedural
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected through study completion (3 years).
|
|
Eye disorders
Anesthesia complications - blurred vision
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected through study completion (3 years).
|
|
Cardiac disorders
Arrhythmia - Bradycardia
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected through study completion (3 years).
|
|
Gastrointestinal disorders
Digestive system disorder - nausea
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected through study completion (3 years).
|
|
Gastrointestinal disorders
Digestive system disorder - vomitting
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected through study completion (3 years).
|
|
Cardiac disorders
Hypertension - acute
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected through study completion (3 years).
|
|
General disorders
Pain - head
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected through study completion (3 years).
|
|
Infections and infestations
Respiratory Abnormalities - Upper Respiratory Infection
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected through study completion (3 years).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60