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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01831895
Recruitment Status : Active, not recruiting
First Posted : April 15, 2013
Last Update Posted : February 26, 2018
Information provided by (Responsible Party):
Vascular Dynamics, Inc.

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

Condition or disease Intervention/treatment
Hypertension Device: MobiusHD™

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 2013
Primary Completion Date : December 2017
Estimated Study Completion Date : June 2020

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. PERFORMANCE [ Time Frame: 6 Months ]
    Decrease in office cuff blood pressure (BP).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831895

United States, Alabama
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30308
United States, Iowa
Iowa Heart Center
Des Moines, Iowa, United States, 50309
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, New York
University of Rochester
Rochester, New York, United States, 14627
United States, Ohio
The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, Tennessee
Turkey Creek Medical Center
Knoxville, Tennessee, United States, 37934
Sponsors and Collaborators
Vascular Dynamics, Inc.
Principal Investigator: Mark C Bates, MD West Virginia University

Responsible Party: Vascular Dynamics, Inc.
ClinicalTrials.gov Identifier: NCT01831895     History of Changes
Other Study ID Numbers: CALM-FIM_US, CRD0152, G130013
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

Keywords provided by Vascular Dynamics, Inc.:
Carotid Sinus

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases