Controlling and Lowering Blood Pressure With The MOBIUSHD™ (CALM-FIM_US)
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ClinicalTrials.gov Identifier: NCT01831895 |
Recruitment Status
:
Active, not recruiting
First Posted
: April 15, 2013
Last Update Posted
: February 26, 2018
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Tracking Information | ||||
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First Submitted Date ICMJE | April 9, 2013 | |||
First Posted Date ICMJE | April 15, 2013 | |||
Last Update Posted Date | February 26, 2018 | |||
Actual Study Start Date ICMJE | May 2013 | |||
Actual Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01831895 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
PERFORMANCE [ Time Frame: 6 Months ] Decrease in office cuff blood pressure (BP).
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Controlling and Lowering Blood Pressure With The MOBIUSHD™ | |||
Official Title ICMJE | CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study | |||
Brief Summary | To evaluate the safety and performance of the MobiusHD system in subjects with resistant 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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hypertension | |||
Intervention ICMJE | Device: MobiusHD™
Implant that is placed in the carotid sinus to control hypertension. |
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Study Arms | Experimental: MobiusHD™
MobiusHD™
Intervention: Device: MobiusHD™ |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Estimated Enrollment ICMJE |
20 | |||
Original Estimated Enrollment ICMJE |
10 | |||
Estimated Study Completion Date | June 2020 | |||
Actual Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01831895 | |||
Other Study ID Numbers ICMJE | CALM-FIM_US, CRD0152, G130013 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Vascular Dynamics, Inc. | |||
Study Sponsor ICMJE | Vascular Dynamics, Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Vascular Dynamics, Inc. | |||
Verification Date | February 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |