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Background: Results from the single-arm first-in-man study of a novel investigational endovascular barostimulation device (Mobius HD) demonstrated safe use and clinically significant reduction from baseline to 180-days post-treatment in mean 24-hour ambulatory blood pressure in 40 patients with resistant hypertension (RHTN). We herein introduce an international, multi-center, blinded, randomized controlled, pivotal trial designed to evaluate the safety and effectiveness of the MobiusHD.
Methods: Approximately 300 patients with RHTN will be enrolled in the CALM-II study in up to 45 centers across the US, UK, and EU. Eligibility criteria include a baseline mean 24-hour ambulatory systolic blood pressure ≥135 mmHg and <180 mmHg despite stable guideline-directed treatment with up to 5 antihypertensive medications. Study participants will be randomized (1:1 ratio) to receive either the MobiusHD implant or sham surgery. Subjects will remain blinded through one year post-procedure. All subjects treated with the MobiusHD implant will be followed for an additional 24 months (total follow-up of 36 months).
Results: Safety will be assessed using a composite measure, which includes myocardial infarction, death, stroke, device embolization, carotid occlusion, and new ipsilateral carotid stenosis requiring surgical or percutaneous intervention at the 90-day follow-up. Primary efficacy endpoint is change in mean 24-hr ambulatory systolic blood pressure (24hr aSBP) from baseline to the 90-day visit. Secondary outcomes include change in mean daytime, nighttime and 24hr aSBP from baseline to the 365-day visit. Exploratory outcomes include change in number and dosage of antihypertensive medications from baseline to 90 and 365 days, change in quality of life scores; and change in healthcare utilization due to hypertension.
Conclusions: Based on initial positive results in a small patient population, and recent trial failures in other device interventions for RHTN, the CALM-II study evaluates a novel investigational device intended to address an ongoing unmet need in hypertension treatment.
Poster Hall, Hall C
Friday, March 17, 2017, 3:45 p.m.-4:30 p.m.
Session Title: Novel Mechanical Devices for the Treatment and Assessment of Hypertension
Abstract Category: 33. Prevention: Hypertension
Presentation Number: 1146-035
- 2017 American College of Cardiology Foundation