CALM FIM: Controlling and lowering blood pressure with the Mobius HD: A prospective multicenter safety study
Short Description:To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
This is an open-label, multicenter, first-in-man clinical trial to evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension. 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.
About 1 in 3 adults in the United States has high blood pressure. High blood pressure could lead to kidney disease, heart disease and/or stroke. Lifestyle changes are not effective in managing high blood pressure and drugs are not effective in many patients either because of non-compliance, adverse reactions to medications or resistance to hypertension medications.
The concept behind this study is that the Mobius implant enhances the signal that is received by the baroreceptor bed surrounding the carotid sinus. The increased baroreceptor bed impulses provides increased afferent nerve activity to the CNS which compensates and lowers blood pressure
Please contact Kate Dalton, MS, RD, CCRC at firstname.lastname@example.org if you have questions or would like to refer a patient.
Principal Investigator: Ajay Kirtane, MD