CALM-FIM_US: Controlling and Lowering Blood Pressure With The MOBIUSHD™

• Sponsor: Vascular Dynamics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01831895
• Collaborator: (none)
• Enrollment: 17
• Locations: 7
• Arm: 1
• Actual Duration (Months): 95.4
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Device: MobiusHD™	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study
• Actual Study Start Date: May 1, 2013
• Actual Primary Completion Date: Jul 8, 2020
• Actual Study Completion Date: Apr 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MobiusHD™ MobiusHD™	Device: MobiusHD™; Implant that is placed in the carotid sinus to control hypertension.

Outcome Measures

Primary Outcome Measures

1. Adverse Events [3 years]

   Number of Participants with Adverse Events

Secondary Outcome Measures

1. Change in Systolic Office Blood Pressure (OBP) [3 years]

   Change in Systolic Office Blood Pressure (OBP) compared to baseline.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology, P.C.	Birmingham	Alabama	United States	35211
2	Emory University	Atlanta	Georgia	United States	30308
3	Iowa Heart Center	Des Moines	Iowa	United States	50309
4	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
5	University of Rochester	Rochester	New York	United States	14627
6	The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital	Cincinnati	Ohio	United States	45219
7	Turkey Creek Medical Center	Knoxville	Tennessee	United States	37934

Sponsors and Collaborators

• Vascular Dynamics, Inc.

Investigators

• Principal Investigator: Mark C Bates, MD, West Virginia University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 8, 2014

More Information

Publications

None provided.

• Responsible Party: Vascular Dynamics, Inc.
• ClinicalTrials.gov Identifier: NCT01831895
• Other Study ID Numbers: CALM-FIM_US, CRD0152, G130013
• First Posted: Apr 15, 2013
• Last Update Posted: Mar 3, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Vascular Dynamics, Inc.: Hypertension; Carotid Sinus
• Additional relevant MeSH terms: Hypertension

Study Results

Participant Flow

Arm/Group Title	MobiusHD™
Arm/Group Description	MobiusHD™ MobiusHD™: Implant that is placed in the carotid sinus to control hypertension.
Period Title: Overall Study
STARTED	17
COMPLETED	15
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	MobiusHD™
Arm/Group Description	MobiusHD™ MobiusHD™: Implant that is placed in the carotid sinus to control hypertension.
Overall Participants	17
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	55.4
Sex: Female, Male (Count of Participants)
Female	8 47.1%
Male	9 52.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 35.3%
White	11 64.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	17 100%
Systolic Office Blood Pressure (mmHg) [Mean (Full Range) ]
Mean (Full Range) [mmHg]	177

Outcome Measures

1. Primary Outcome

Title	Adverse Events
Description	Number of Participants with Adverse Events
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MobiusHD™
Arm/Group Description	MobiusHD™ MobiusHD™: Implant that is placed in the carotid sinus to control hypertension.
Measure Participants	17
Hypotension - acute	1 5.9%
Abnormal lab finding - hypokalemia	1 5.9%
Access site complication - hemorrhage - groin	1 5.9%
Access site complication - postprocedural	1 5.9%
Anesthia complications - blurred vision	1 5.9%
Digestive system disorder - nausea	1 5.9%
Digestive system disorder - vomiting	1 5.9%
Hypertension - acute	1 5.9%
Pain - head	1 5.9%
Pain - puncture site	2 11.8%
Respiratory abnormalities - upper respiratory infection	1 5.9%

2. Secondary Outcome

Title	Change in Systolic Office Blood Pressure (OBP)
Description	Change in Systolic Office Blood Pressure (OBP) compared to baseline.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

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/Group Title	MobiusHD™
Arm/Group Description	MobiusHD™ MobiusHD™: Implant that is placed in the carotid sinus to control hypertension.
Measure Participants	17
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)

3. Secondary Outcome

Title	Change in Systolic Ambulatory Blood Pressure (ABPM)
Description	Change in Systolic Ambulatory Blood Pressure (ABPM) measured at 3 and 6 months compared to baseline values.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Of the 17 subjects enrolled in the study, 16 subjects were available for for systolic ABPM measurements at 3 and 6 months.

Arm/Group Title	MobiusHD™
Arm/Group Description	MobiusHD™ MobiusHD™: Implant that is placed in the carotid sinus to control hypertension.
Measure Participants	16
3 months	-11.94 (19.69)
6 months	-16.00 (17.91)

Adverse Events

Time Frame	Adverse event data were collected through study completion (3 years).
Arm/Group Title	MobiusHD™
Arm/Group Description	MobiusHD™ MobiusHD™: Implant that is placed in the carotid sinus to control hypertension.
All Cause Mortality
	MobiusHD™
	Affected / at Risk (%)	# Events
Total	1/17 (5.9%)
Serious Adverse Events
	MobiusHD™
	Affected / at Risk (%)	# Events
Total	1/17 (5.9%)
General disorders
Hypotension - acute	1/17 (5.9%)	1
Other (Not Including Serious) Adverse Events
	MobiusHD™
	Affected / at Risk (%)	# Events
Total	7/17 (41.2%)
Blood and lymphatic system disorders
Abnormal lab finding - hypokalemia	1/17 (5.9%)	1
Cardiac disorders
Arrhythmia - Bradycardia	1/17 (5.9%)	1
Hypertension - acute	1/17 (5.9%)	1
Eye disorders
Anesthesia complications - blurred vision	1/17 (5.9%)	1
Gastrointestinal disorders
Digestive system disorder - nausea	1/17 (5.9%)	1
Digestive system disorder - vomitting	1/17 (5.9%)	1
General disorders
Pain - head	1/17 (5.9%)	1
Infections and infestations
Respiratory Abnormalities - Upper Respiratory Infection	1/17 (5.9%)	1
Skin and subcutaneous tissue disorders
Pain - puncture site	2/17 (11.8%)	2
Access site complication - hemorrhage - groin	1/17 (5.9%)	1
Access site complications - postprocedural	1/17 (5.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.