Trial Outcomes & Findings for Controlling and Lowering Blood Pressure With The MOBIUS HD™ (CALM-FIM_EUR) (NCT NCT01911897)

NCT ID: NCT01911897

Last Updated: 2023-11-22

Results Overview

The number of participants with serious adverse events reported in the study will be tabulated.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 36 months
• Results posted on: 2023-11-22

Participant Flow

Participant milestones

Measure	MobiusHD MobiusHD MobiusHD: Implant that is placed in the carotid sinus to control hypertension.
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Controlling and Lowering Blood Pressure With The MOBIUS HD™ (CALM-FIM_EUR)

Baseline characteristics by cohort

Measure	MobiusHD n=30 Participants MobiusHD MobiusHD: Implant that is placed in the carotid sinus to control hypertension.
Age, Continuous	52.4 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment Netherlands	2 participants n=5 Participants
Region of Enrollment Germany	28 participants n=5 Participants
Systolic Office Blood Pressure	184 mmHg STANDARD_DEVIATION 18.4 • n=5 Participants
24-Hour Ambulatory Blood Pressure (Systolic Blood Pressure)	167 mmHg STANDARD_DEVIATION 16.6 • n=5 Participants

PRIMARY outcome

Timeframe: 36 months

The number of participants with serious adverse events reported in the study will be tabulated.

Outcome measures

Measure	MobiusHD n=30 Participants MobiusHD MobiusHD: Implant that is placed in the carotid sinus to control hypertension.
Number of Participants With Serious Adverse Events (SAEs)	8 Participants

SECONDARY outcome

Timeframe: Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months

Outcome measures

Measure	MobiusHD n=30 Participants MobiusHD MobiusHD: Implant that is placed in the carotid sinus to control hypertension.
Systolic Office Cuff Blood Pressure (BP) Baseline	184 mmHg Standard Deviation 18.4
Systolic Office Cuff Blood Pressure (BP) Discharge (up to 2 days)	147 mmHg Standard Deviation 22.2
Systolic Office Cuff Blood Pressure (BP) 7 days	157 mmHg Standard Deviation 27.3
Systolic Office Cuff Blood Pressure (BP) 1 month	162 mmHg Standard Deviation 30.6
Systolic Office Cuff Blood Pressure (BP) 3 months	160 mmHg Standard Deviation 28.4
Systolic Office Cuff Blood Pressure (BP) 6 months	160 mmHg Standard Deviation 26.1

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months

Outcome measures

Measure	MobiusHD n=30 Participants MobiusHD MobiusHD: Implant that is placed in the carotid sinus to control hypertension.
Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months Baseline	167 mmHg Standard Deviation 16.6
Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months 3 months	150 mmHg Standard Deviation 19.1
Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months 6 months	145 mmHg Standard Deviation 19.1

Adverse Events

MobiusHD

Serious events: 8 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	MobiusHD n=30 participants at risk MobiusHD MobiusHD: Implant that is placed in the carotid sinus to control hypertension.
Cardiac disorders Hypertensive Emergency	6.7% 2/30 • Number of events 2 • 36 months
Cardiac disorders Hypotension - chronic	6.7% 2/30 • Number of events 2 • 36 months
Cardiac disorders Relative hypotension - acute	3.3% 1/30 • Number of events 1 • 36 months
General disorders Stroke with permanent symptoms	3.3% 1/30 • Number of events 1 • 36 months
General disorders Transient ischemic attack	3.3% 1/30 • Number of events 1 • 36 months
General disorders Access site complications	6.7% 2/30 • Number of events 2 • 36 months

Other adverse events

Measure	MobiusHD n=30 participants at risk MobiusHD MobiusHD: Implant that is placed in the carotid sinus to control hypertension.
General disorders Access site complications	16.7% 5/30 • Number of events 5 • 36 months
General disorders Dizziness	20.0% 6/30 • Number of events 6 • 36 months
Cardiac disorders Hypotension - acute	6.7% 2/30 • Number of events 2 • 36 months
General disorders Pain	26.7% 8/30 • Number of events 9 • 36 months
Cardiac disorders Relative hypotension - acute	6.7% 2/30 • Number of events 2 • 36 months
General disorders Skin sensation disturbance	10.0% 3/30 • Number of events 3 • 36 months
General disorders Transient ischemic attack	6.7% 2/30 • Number of events 2 • 36 months

Additional Information

Director, Clinical Operations

Vascular Dynamics

Phone: 9492317602

Email: lgreen@vasculardynamics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place