MobiusHD Device for High Blood Pressure

(CALM-2 Trial)

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

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study.

Who Is on the Research Team?

Gregg Stone, MD

Principal Investigator

Cardiovascular Research and Education Columbia University Medical Center

Bryan Williams, MD

Principal Investigator

University College, London

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+