Controlling and Lowering Blood Pressure With the MobiusHD™ (CALM-DIEM)

Vascular Dynamics

Status: Enrolling

Conditions: Hypertension

Treatments: Device: MobiusHD™

Study type: Interventional

Funder types: Industry

Identifiers

NCT02827032

CRD0328

Details and patient eligibility

About

To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.

Full description

The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mean 24-hour systolic ABPM is ≥130 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medication or dose), and no more than 28 days prior to implantation.

Exclusion criteria

• Known or clinically suspected baroreflex failure or autonomic neuropathy

Substudy Eligibility Criteria: A maximum of 16 patients will be enrolled in the sub-study at one site (Universitair Medisch Centrum Utrecht)

Inclusion Criteria:

• Patients must be eligible for the main study and must have passed all CALM-DIEM study inclusion and exclusion criteria at time of screening

Exclusion Criteria:

• Use of anti-hypertensive drugs directly acting on the sympathetic nervous system that cannot be discontinued safely
• Underlying conditions that prohibit microneurography, performance of a Valsalva maneuver and/or magnetic resonance imaging

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

MobiusHD™

Experimental group

Description:

The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.

Treatment:

Device: MobiusHD™