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

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: NCT01911897
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Vascular Dynamics, Inc.

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

Condition or disease Intervention/treatment Phase
Hypertension Device: MobiusHD Not Applicable

Detailed Description:

This is an open-label, multicenter, first-in-man clinical trial to be conducted in Europe. 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CALM-FIM_EUR - Controlling and Lowering Blood Pressure With the MobiusHD - A Prospective Multicenter Safety Study
Actual Study Start Date : June 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: 6 months ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 unless patient has history of intolerance, ineffectiveness or contraindications. 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
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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): NCT01911897


Locations
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Germany
University of Cologne
Cologne, Germany, 50937
Netherlands
Maastricht University Medical Center
Maastricht, AZ, Netherlands, 6202
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430 EM
Erasmus Medical Center
Rotterdam, Netherlands, 3015
HagaZiekenhuis
The Hague, Netherlands, 2545 CH
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
Vascular Dynamics, Inc.
Investigators
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Principal Investigator: Jan Van der Heyden, MD St. Antonius ziekenhuis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vascular Dynamics, Inc.
ClinicalTrials.gov Identifier: NCT01911897    
Other Study ID Numbers: CRD0120, CRD0233
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Keywords provided by Vascular Dynamics, Inc.:
Hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases