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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vascular Dynamics, Inc.
ClinicalTrials.gov Identifier:
NCT01831895
First received: April 9, 2013
Last updated: June 24, 2016
Last verified: June 2016
  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

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).


Enrollment: 10
Study Start Date: May 2013
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2016 (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   (Adult, Senior)
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

Locations
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, Michigan
Michigan Heart
Ypsilanti, Michigan, United States, 48197
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.
Investigators
Principal Investigator: Mark C Bates, MD West Virginia University
  More Information

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 24, 2016
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 August 22, 2016