MobiusHD Device for High Blood Pressure

(CALM-2 Trial)

Not currently recruiting at 39 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vascular Dynamics, Inc.

Must be taking: Ace inhibitors, Calcium blockers, Diuretics

Disqualifiers: Inadequate carotid anatomy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 90

Duration: 180 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the MobiusHD to determine if it can safely and effectively lower high blood pressure. The study compares two groups: one receives the real MobiusHD device, while the other undergoes a sham (fake) procedure. It targets individuals who have struggled with high blood pressure (145-200 mmHg) for at least 8 weeks, despite taking up to 5 different blood pressure medications. Participants will help researchers assess whether this new method works better than relying solely on medication. As an unphased trial, this study offers patients a unique opportunity to contribute to groundbreaking research in blood pressure management.

Do I have to stop taking my current medications for the trial?

The trial requires you to continue taking your current blood pressure medications, specifically a combination of an ACE inhibitor or angiotensin receptor blocker, a calcium channel blocker, and a diuretic.

What prior data suggests that the MobiusHD device is safe for high blood pressure?

Research has shown that the MobiusHD device is generally safe for people with high blood pressure. One study found that it lowered blood pressure over three years and was usually well-tolerated by patients. Another study noted improvements in quality of life and exercise ability, with no major safety issues. However, more detailed studies are needed to fully understand its long-term safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MobiusHD device because it offers a novel approach to treating high blood pressure, unlike standard treatments such as medications that target blood vessel constriction or fluid retention. The MobiusHD device is implanted to work on the carotid artery, using a new mechanism that potentially recalibrates the body's natural blood pressure regulation system. This method could provide a more sustained and effective way to manage hypertension, especially for patients who don't respond well to conventional medication. Additionally, the implant approach might reduce the need for multiple daily medications, simplifying treatment for patients.

What evidence suggests that the MobiusHD device is effective for high blood pressure?

In this trial, participants will receive either the MobiusHD device or undergo a sham implantation. Studies have shown that the MobiusHD device can lower blood pressure in people with resistant hypertension, which is high blood pressure that doesn't respond well to treatment. One study found that patients using the MobiusHD device experienced a significant drop in blood pressure over three years, and the device proved to be safe. The MobiusHD enhances the body's natural ability to control blood pressure by calming the part of the nervous system that manages stress. This device is placed in the carotid arteries, which are important blood vessels in the neck. Overall, research suggests that the MobiusHD could be a promising option for managing high blood pressure. ^{1 3 5 6 7}

Who Is on the Research Team?

Bryan Williams, MD

Principal Investigator

University College, London

Gregg Stone, MD

Principal Investigator

Cardiovascular Research and Education Columbia University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with high blood pressure that's stayed high (145-200 mmHg) despite taking up to 5 different blood pressure meds, including a specific combo of an ACE inhibitor or angiotensin receptor blocker, calcium channel blocker, and diuretic. People can't join if their carotid artery anatomy isn't right for the MobiusHD device based on special X-ray tests.

Inclusion Criteria

My blood pressure is high despite taking a mix of up to 5 blood pressure medications.

Exclusion Criteria

Your carotid arteries are not suitable for treatment with the MobiusHD based on a special type of x-ray called carotid angiography.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the MobiusHD Implantation or a sham procedure

180 days

Baseline, 90-day, and 180-day visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MobiusHD
• Sham Implantation

Trial Overview The CALM-2 study is testing how safe and effective the MobiusHD System is at lowering blood pressure compared to a fake procedure. Participants won't know which one they get in this controlled study where treatments are assigned randomly.

How Is the Trial Designed?

Group I: MobiusHD Implantation Experimental Treatment 1 Intervention

MobiusHD Implantation

Group II: Sham Implantation Placebo Group 1 Intervention

Sham Implantation

MobiusHD is already approved in European Union, United States for the following indications:

Approved in European Union as MobiusHD for:

• Hypertension
• Heart failure with reduced ejection fraction

Approved in United States as MobiusHD for:

• Resistant hypertension
• Heart failure with reduced ejection fraction (under investigation)

Who Is Running the Clinical Trial?

Vascular Dynamics, Inc.

Lead Sponsor

Trials

7

Recruited

600+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1936879821021671

3-Year Results From the CALM-FIM Study EVBA with the MobiusHD was effective in reducing BP at 3-year follow-up and appears to have an acceptable safety profile in patients with uncomplicated ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7453969/

Device profile of the MobiusHD EVBA system for the treatment ... We describe the innovation process leading to the first endovascular carotid baroreflex amplification device currently undergoing clinical trials.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02827032

NCT02827032 | Controlling and Lowering Blood Pressure ... To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension. Detailed Description.

4. jacc.org jacc.org/doi/abs/10.1016/j.jcin.2021.12.015

3-Year Results From the CALM-FIM Study The CALM-FIM study demonstrated that EVBA in patients with resistant hypertension significantly lowered blood pressure (BP) with an acceptable safety profile ...

5. structuralheartjournal.org structuralheartjournal.org/article/S2474-8706(22)01876-0/fulltext

Endovascular Baroreflex Amplification With the MobiusHD ... The MobiusHD device is designed to reduce sympathetic overactivity in heart failure. It's implanted in nondiseased carotid arteries and amplifies baroreceptor ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01911897

NCT01911897 | Controlling and Lowering Blood Pressure ... Study Overview. Brief Summary. To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension. Detailed Description.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10242580/

Endovascular Baroreflex Amplification With the MobiusHD ... Endovascular baroreflex amplification with the MobiusHD device was safe and effected positive changes in quality of life, exercise capacity, and LVEF.