RecruitingNAINTERVENTIONAL

Controlling and Lowering Blood Pressure With the MobiusHD™

This study, called CALM-DIEM, is looking at a device called MobiusHD™ for people whose high blood pressure is very difficult to control, even with medication. It's an important check to make sure the device works well and is safe after it’s already available for use. The study will follow patients who have had the MobiusHD™ device fitted. Researchers want to see if their blood pressure comes down and stays down. It's for adults aged 18 to 80, and everyone is welcome to take part if they meet the specific health requirements. The main goal is to understand the real-world performance of the MobiusHD™ system.

At a glance

Status

Recruiting

Phase

Sponsor

Vascular Dynamics, Inc.

Enrolment target

200

Start

01 Jul 2016

Estimated completion

01 Jun 2026

Hypertension

What is this study about?

This research study, known as CALM-DIEM, is designed to keep a close eye on a medical device called MobiusHD™ once it's already being used by patients. Think of it like a thorough follow-up check. The device is intended for people who have stubbornly high blood pressure that hasn't responded well to normal medications – a condition sometimes called 'resistant hypertension'. The study aims to confirm that the MobiusHD™ system is performing as expected and is safe for these patients.

The main purpose of this study is to gather more information about how the MobiusHD™ device works in everyday situations. Researchers will look at how well it helps control blood pressure levels in patients who have received the device. By carefully observing these patients over time, the study hopes to add to our understanding of how effective and reliable the MobiusHD™ is for people who need extra help managing their high blood pressure.

This is an 'open-label, prospective, multicenter study', which means both the patients and the doctors will know who is receiving the MobiusHD™ device. It will take place at several different hospitals and clinics, and researchers will follow patients forward in time after they have had the device fitted. This type of study is crucial for ensuring that medical devices continue to meet high standards of safety and effectiveness after they are available for use.

Key takeaways

This study is about a device for hard-to-treat high blood pressure.
It's for people who have already been chosen to have the MobiusHD™ device.
The study checks how well the device works and if it's safe over time.
Adults aged 18-80 with very high blood pressure might be eligible.
Your doctors will monitor your health and blood pressure regularly.
You can stop participating at any time without affecting your care.

Who may be eligible?

To join this study, your doctor would first need to confirm that your blood pressure, measured over a full 24 hours, is still high (at least 130 mmHg for the top number) even after you’ve been taking your blood pressure medications regularly for at least a month. Your medications must have been stable, meaning no changes in dose or type, for this period.

It’s important that you don't have certain conditions that could affect a measure of your body's automatic functions, such as nerve problems that might interfere with how your body controls blood pressure. If you have these or similar issues, you wouldn't be able to join the main part of the study.

There's also a smaller part of the study at one specific hospital in Utrecht, Netherlands. For this smaller group, in addition to the main study requirements, you can't be taking certain blood pressure medicines that affect your nervous system if they can't be safely stopped. Also, you can't have conditions that would prevent specific tests like microneurography (a nerve test), performing a Valsalva maneuver (a breathing exercise), or having an MRI scan.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 80 years old?
Is your high blood pressure still high (24-hour reading of 130 mmHg or more systolic) even with medication?
Have you been on stable blood pressure medication for at least 30 days?
Do you have no known nerve conditions that affect blood pressure control?

Answer every question to see your result.

What does participation involve?

If you join this study, it means you have already been chosen to receive the MobiusHD™ device as part of your treatment. The study will then involve following you over time to see how the device is working. This will likely include regular visits to your clinic or hospital for check-ups. During these visits, doctors and nurses will monitor your blood pressure and overall health. They might ask you to complete questionnaires or undergo specific tests to assess the device's performance. The exact number of visits, tests, and the total length of your participation will be explained in detail by your study team. You will continue to take any prescribed medications as advised by your doctor, and any changes will be carefully managed.

Potential risks and benefits

Taking part in this study means you'll be part of a group helping us understand more about how the MobiusHD™ device works for people with resistant high blood pressure. While there's no guarantee the device will cure your high blood pressure, it's hoped that it will help control it better, which could lead to better long-term health. As with any medical procedure or device, there are always potential risks involved, which your doctor will discuss fully with you before you decide to take part. These could be risks associated with the device itself or the procedures for monitoring it. You are free to decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Universitätsmedizin Mannheim
Verified postcode
Mannheim, Germany· Withdrawn
CVC Frankfurt
Verified postcode
Frankfurt am Main, Germany· Recruiting
Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany· Withdrawn
Uniklinik Köln
Verified postcode
Cologne, Germany· Completed
Universitätsklinikum Düsseldorf
Verified postcode
Düsseldorf, Germany· Completed
Universitätsklinikum Schleswig-Holstein
Verified postcode
Kiel, Germany· Withdrawn
Charite Berlin
Verified postcode
Berlin, Germany· Withdrawn
Asklepiod Klinik Hamburg
Verified postcode
Hamburg, Germany· Completed
Universitatsklinikum des Saarlandes
Verified postcode
Homburg, Germany· Completed
HagaZiekenhuis
Verified postcode
The Hague, Netherlands· Completed
St. Antonius Ziekenhuis
Verified postcode
Nieuwegein, Netherlands· Completed
Maastricht UMC+
Verified postcode
Maastricht, Netherlands· Completed

Common questions

What is MobiusHD™?

MobiusHD™ is a medical device designed to help manage high blood pressure that hasn't responded well to other treatments.

Who can take part in this study?

Adults aged 18 to 80 whose high blood pressure is still high after stable medication, and who don't have certain nerve conditions, might be eligible.

What does 'resistant hypertension' mean?

It means high blood pressure that is difficult to get under control, even when someone is taking several different blood pressure medications properly.

Will I get the MobiusHD™ device if I join?

This study is for patients who have already been chosen by their doctors to receive the MobiusHD™ device as part of their treatment.

What are the benefits of joining?

You would be contributing to important medical research and helping doctors learn more about the MobiusHD™ device for people with difficult-to-treat high blood pressure.

How to find out more

Lisa Green

lgreen@vasculardynamics.com 949.231.7602 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.