CALM DIEM
Research type
Research Study
Full title
CALM- DIEM – CONTROLLING AND LOWERING BLOOD PRESSURE WITH THE MOBIUSHD™ – DEFINING EFFICACY MARKERS
IRAS ID
208944
Contact name
Bryan Williams
Contact email
Sponsor organisation
Vascular Dynamics, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, 1 days
Research summary
The purpose of this study is to measure the benefits and the safety of treatment with the MobiusHD™ system in research participants with refractory hypertension. Hypertension is a condition where blood pressure of the affected person is above the normal range. Since the increase in pressure may go unnoticed, over time, this increase in blood pressure is known to cause damage to the heart, the blood vessels, the kidneys and the eyes. 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. The objective of this study is to perform post-market surveillance and evaluate the performance of the MobiusHD™ System in participants with primary resistant hypertension. In order to participate in this study, patients must have a mean 24-hour systolic ABPM of ≥130mmHg following at least 30 days on a stable anti-hypertensive medication regimen. Up to 200 participants may be enrolled at up to 50 sites in the UK, Germany, the Netherlands and the US. Eligible subjects with primary resistant hypertension who consent to study participation will be followed for three (3) years.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0076
Date of REC Opinion
8 May 2017
REC opinion
Further Information Favourable Opinion