Controlling and Lowering Blood Pressure With The MOBIUSHD™ (CALM-FIM_US)
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
|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|
- 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.
- PERFORMANCE [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Decrease in office cuff blood pressure (BP).
|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)|
Implant that is placed in the carotid sinus to control hypertension.
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.
|Contact: Sujith J Shetty, MBBSfirstname.lastname@example.org|
|United States, Georgia|
|Atlanta, Georgia, United States, 30308|
|Contact: Theresa Sanders, MN, RN 404-686-3872|
|Principal Investigator: Chandan Devireddy, 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 email@example.com|
|Principal Investigator: Ajay Kirtane, MD|
|Principal Investigator:||Mark C Bates, MD||West Virginia University|