Controlling And Lowering Blood Pressure With the MobiusHDTM Device

CALM-START - Controlling And Lowering Blood Pressure With the MobiusHDTM Device: STudying Effects in A Randomized Trial

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02804087

Acronym

CALM-START

Enrollment

Registered

2016-06-17

Start date

2017-08-24

Completion date

2021-07-21

Last updated

2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

Detailed 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.

Interventions

DEVICEMobiusHD

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

OTHERSham Implantation

Sham Implantation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The change in mean systolic 24-hour ABP from baseline to 90 days post-randomization, between the treatment arm and the sham arm.	From Baseline to 90 days post-randomization	Reduction in mean systolic 24-hour ABP

Secondary

Measure	Time frame	Description
Major adverse clinical events, including death, stroke, carotid interventions, and myocardial infarction, from baseline to 30 days post-randomization, between the treatment arm and the sham arm.	From Baseline to 30 days post-randomization	Adverse Events

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026