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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Vascular Dynamics, Inc.
Sponsor:
Information provided by (Responsible Party):
Vascular Dynamics, Inc.
ClinicalTrials.gov Identifier:
NCT01831895
First received: April 9, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Hypertension
Device: MobiusHD™
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study

Resource links provided by NLM:


Further study details as provided by Vascular Dynamics, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • PERFORMANCE [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Decrease in office cuff blood pressure (BP).


Estimated Enrollment: 10
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MobiusHD™
MobiusHD™
Device: MobiusHD™
Implant that is placed in the carotid sinus to control 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831895

Contacts
Contact: Sujith J Shetty, MBBS 650-963-9370 sshetty@vasculardynamics.com

Locations
United States, California
El Camino Hospital Recruiting
Mountain View, California, United States, 94040
Contact: Betty deBettencourt, RN, MS, CCRC    650-962-4566    betty.debettencourt@fogartyinstitute.org   
Principal Investigator: James Joye, D.O.         
Sub-Investigator: Ajanta De, MD         
UC Davis Vascular Center Recruiting
Sacramento, California, United States, 95817
Contact: Kimberley Book, RN, BS, CCRP    916-734-5639    kimberley.book@ucdmc.ucdavis.edu   
Principal Investigator: John Laird, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30308
Contact: Theresa Sanders, MN, RN    404-686-3872      
Principal Investigator: Chandan Devireddy, MD         
United States, Iowa
Iowa Heart Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Tanya Watters, RN    515-235-5089    twatters@iowaheart.com   
Contact: Teresa Coulson, RN, CCRC    515-633-3840    tcoulson@iowaheart.com   
Principal Investigator: Magdhi Ghali, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Kate Dalton, MS, RD    212-342-1820    keb2114@cumc.columbia.edu   
Principal Investigator: Ajay Kirtane, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Adrienne Harvey       harveya2@ccf.org   
Contact: Tony Isabella       isabelt@ccf.org   
Principal Investigator: Mehdi Shishehbor, D.O.         
United States, Tennessee
Turkey Creek Medical Center Recruiting
Knoxville, Tennessee, United States, 37934
Contact: Beth Polk, RN, CCRC    865-218-7535    beth.polk@hma.com   
Contact: Connie Bales, RN, CCRC    865-218-7540    constance.bales@hma.com   
Principal Investigator: Malcolm Foster, MD         
United States, Wisconsin
Medical College of Wisconsin - Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Ashley Farrow-Schmidt, MPH    414-805-5248    afarrow@mcw.edu   
Principal Investigator: Osama O Zaidat, MD, MS         
Sponsors and Collaborators
Vascular Dynamics, Inc.
Investigators
Principal Investigator: Mark C Bates, MD West Virginia University
  More Information

No publications provided

Responsible Party: Vascular Dynamics, Inc.
ClinicalTrials.gov Identifier: NCT01831895     History of Changes
Other Study ID Numbers: CALM-FIM_US, CRD0152, G130013
Study First Received: April 9, 2013
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Vascular Dynamics, Inc.:
Hypertension
Carotid Sinus

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014