Controlling And Lowering Blood Pressure With the MobiusHDTM Device (CALM-START)

Vascular Dynamics

Status: Terminated

Conditions: Hypertension

Treatments: Device: MobiusHD; Other: Sham Implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02804087

CRD0339

Details and patient eligibility

About

To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

Full description

This is a prospective, randomized, double-blind, sham-controlled, multi-center post market study investigating the efficacy and safety of MobiusHD System, and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ABP in subjects with resistant hypertension.

Enrollment: 4 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-70 years;
• Diagnosed with resistant hypertension;
• A mean systolic 24-hour ABP of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose).
• A mean systolic 24-hour ABP of 135-170 mmHg after washout of all antihypertensive medications.

Exclusion criteria

• Known or clinically suspected baroreflex failure or autonomic neuropathy
• Treatable cause of resistant hypertension
• Hypertension secondary to an identifiable and treatable cause other than sleep apnea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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4 participants in 2 patient groups

MobiusHD Implantation

Experimental group

Treatment:

Device: MobiusHD

Sham Implantation

Sham Comparator group

Description:

Sham

Treatment:

Other: Sham Implantation