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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Vascular Dynamics, Inc.
Information provided by (Responsible Party):
Vascular Dynamics, Inc. Identifier:
First received: April 9, 2013
Last updated: December 1, 2015
Last verified: December 2015

April 9, 2013
December 1, 2015
May 2013
June 2016   (final data collection date for primary outcome measure)
Safety [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01831895 on Archive Site
PERFORMANCE [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Decrease in office cuff blood pressure (BP).
PERFORMANCE [ Time Frame: 6 Months ]
Decrease in office cuff blood pressure (BP).
Not Provided
Not Provided
Controlling and Lowering Blood Pressure With The MOBIUSHD™
CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study
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.

Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Device: MobiusHD™
Implant that is placed in the carotid sinus to control hypertension.
Experimental: MobiusHD™
Intervention: Device: MobiusHD™
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2018
June 2016   (final data collection date for primary outcome measure)

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
18 Years to 80 Years
Contact: Sujith J Shetty, MBBS 650-963-9370
United States
CALM-FIM_US, CRD0152, G130013
Not Provided
Not Provided
Vascular Dynamics, Inc.
Vascular Dynamics, Inc.
Not Provided
Principal Investigator: Mark C Bates, MD West Virginia University
Vascular Dynamics, Inc.
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP