CALM- 2 – CONTROLLING AND LOWERING BLOOD PRESSURE WITH THE MOBIUSHD®
Trial objective: The objective of this trial is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal trial. Patients with resistant hypertension who remain uncontrolled despite pharmacologic treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy will be evaluated.
Disease area: Hypertension
Status: Open to recruitment
CI/PI: PI Dr Manish Saxena
Sponsor: Vascular Dynamics Inc
Funder: Vascular Dynamics Inc
The objective of this study is to evaluate the effectiveness and safety of the MobiusHD system in participants with resistant hypertension by comparing the change from baseline to 180 days in 24-hour systolic ABP between the Mobius implant and sham treatment. Hypertension is the leading cause of premature death globally, with elevated blood pressure accounting for, or contributing to 62% of all strokes and 49% of all cases of heart disease, culminating in an estimated 7.1 million deaths per year. Several different types of medications are available to treat hypertension. In many cases, more than one medication is required to adequately lower high blood pressure. However, in some patients, blood pressure remains high even with use of multiple medications. This condition is known as resistant or refractory hypertension. The MobiusHD™ has been approved in the EU for the treatment of patients with refractory hypertension. It is a permanent implant that is placed in a specific area in the carotid artery. This artery contains sensors that control blood pressure through a feedback system called the baroreflex. The MobiusHD™ device is intended to make the blood pressure sensors in the carotid artery more sensitive to feedback signals, indicating that a patient’s blood pressure is too high.
Eligible patients who consent to study participation will be randomized to either treatment or sham treatment.
Participants allocated to the sham procedure will receive the implant after the last participant in the study has reached the primary endpoint should they opt to do so.
Sample size and duration
300; approximately 5 years