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

Tracking Information
First Submitted Date ICMJE	April 9, 2013
First Posted Date ICMJE	April 15, 2013
Last Update Posted Date	February 26, 2018
Actual Study Start Date ICMJE	May 2013
Actual Primary Completion Date	December 2017 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 12, 2013)	Safety [ Time Frame: 6 month ]; Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADE) reported for the study population from implantation through six (6) months of follow-up.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01831895 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 12, 2013)	PERFORMANCE [ Time Frame: 6 Months ]; Decrease in office cuff blood pressure (BP).
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Controlling and Lowering Blood Pressure With The MOBIUSHD™
Official Title ICMJE	CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study
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 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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Hypertension
Intervention ICMJE	Device: MobiusHD™; Implant that is placed in the carotid sinus to control hypertension.
Study Arms	Experimental: MobiusHD™; MobiusHD™; Intervention: Device: MobiusHD™
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Estimated Enrollment ICMJE; (submitted: November 28, 2016)	20
Original Estimated Enrollment ICMJE; (submitted: April 12, 2013)	10
Estimated Study Completion Date	June 2020
Actual Primary Completion Date	December 2017 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01831895
Other Study ID Numbers ICMJE	CALM-FIM_US, CRD0152, G130013
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Vascular Dynamics, Inc.
Study Sponsor ICMJE	Vascular Dynamics, Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Mark C Bates, MD West Virginia University
PRS Account	Vascular Dynamics, Inc.
Verification Date	February 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP