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
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Device: MobiusHD™||Not Applicable|
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)|
|Official Title:||CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study|
|Actual Study Start Date :||May 2013|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2020|
Implant that is placed in the carotid sinus to control hypertension.
- 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.
- PERFORMANCE [ Time Frame: 6 Months ]Decrease in office cuff blood pressure (BP).
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|
|Birmingham, Alabama, United States, 35211|
|United States, Georgia|
|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|
|Principal Investigator:||Mark C Bates, MD||West Virginia University|