CALM-2
Research type
Research Study
Full title
CALM- 2 – CONTROLLING AND LOWERING BLOOD PRESSURE WITH THE MOBIUSHD®
IRAS ID
222492
Contact name
Bryan Williams
Contact email
Sponsor organisation
Vascular Dynamics, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
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.
Up to 300 subjects with a mean 24 hour systolic ABP between 145 and 200 mmHg diagnosed with resistant hypertension while taking a stable antihypertensive medication regimen will be enrolled at up to 45 centers worldwide. 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. All participants will be followed for five years after the procedure.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0228
Date of REC Opinion
5 Oct 2017
REC opinion
Further Information Favourable Opinion