RecruitingOBSERVATIONAL

The "Global Paradise System" Registry

This study, called the "Global Paradise System" Registry, is for people in the UK who have high blood pressure and are being treated with a special procedure called renal denervation using the Paradise Ultrasound System. It's not a new treatment being tested, but rather an observation of how well this already available treatment works in real-world settings and if it is safe over a longer period. Researchers will collect information from patients as part of their routine care, including blood pressure measurements taken at home and details about their quality of life. This helps them understand the long-term effects of the Paradise system when used as intended by doctors.

At a glance

Status

Recruiting

Sponsor

ReCor Medical, Inc.

Enrolment target

3,000

Start

13 Jan 2022

Estimated completion

31 Dec 2031

Hypertension

What is this study about?

This study is called the "Global Paradise System" Registry. It's designed to keep an eye on a treatment for high blood pressure called renal denervation, specifically using a device called the Paradise Ultrasound System. This treatment is already approved and used in some patients, so this study isn't testing something brand new. Instead, it's observing how well it works and if it's safe for patients in the long run when used in typical medical practice.

Imagine you have high blood pressure that hasn't been fully controlled by medications. Your doctor might suggest renal denervation. This procedure involves using sound waves (ultrasound) to treat certain nerves near your kidneys that contribute to high blood pressure. The aim is to help lower your blood pressure. This study wants to gather more information on how effective this is and what the long-term experience is for people who have this treatment.

Researchers will collect information from patients over time. This includes details from your routine medical appointments, your blood pressure readings you take at home, and how you feel about your quality of life. All this information helps doctors understand the full picture of how the Paradise Ultrasound System helps people with high blood pressure.

Key takeaways

This study observes an existing high blood pressure treatment.
It's for people who have had or are considering renal denervation with the Paradise System.
It collects information on long-term safety and how well the treatment works.
You'll share home blood pressure readings and your quality of life experiences.
Participation involves no new medical procedures or medications.
It helps gather important information for future patients.

Who may be eligible?

To join this study, you must be at least 18 years old and have agreed to take part by signing a consent form. You might be considered if your doctor thinks the Paradise Ultrasound Renal Denervation System is a good treatment option for your high blood pressure, or if you've already had this treatment within the last six months.

There are certain reasons why you wouldn't be able to join. For example, if you're pregnant, or if you have certain conditions with your kidney arteries like they are very narrow, have a blockage, or have had a stent put in. You also wouldn't be eligible if you're allergic to the special dye used in some medical scans (contrast medium) or if you have certain problems with other blood vessels that would make the procedure difficult.

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 18 years old or older?
Have you signed a consent form to take part?
Has your doctor said you are a candidate for renal denervation with the Paradise System, or have you had it within the last 6 months?
Are you NOT pregnant?
Do you NOT have a known allergy to contrast dye?
Do you NOT have certain specific problems with your kidney blood vessels (e.g., severe narrowing, previous stent, aneurysm)?

Answer every question to see your result.

What does participation involve?

If you join this study, it's generally about collecting information from your standard medical care and adding a few extra checks. You'll continue with your usual doctor's appointments and treatments for high blood pressure. The study will mainly involve collecting information that your doctor already records, such as your blood pressure readings.

In addition, you'll be asked to measure your blood pressure at home regularly. You'll also fill out a short questionnaire from time to time about your quality of life – basically, how you're feeling and how your high blood pressure impacts your daily life. The study doesn't involve any extra procedures or taking new medications specifically for the research beyond what your doctor has already prescribed. The total length of your participation would depend on how long the registry is collecting data, but it focuses on long-term follow-up.

Potential risks and benefits

The main benefit of joining this study is that it helps doctors learn more about the long-term safety and effectiveness of the Paradise Ultrasound Renal Denervation System for people with high blood pressure, which could help future patients. Because this is an observational study and you're already receiving the treatment as part of your normal care, there are no additional medical risks from the study itself. Any risks related to the Paradise System procedure itself would have been discussed with you by your doctor before you had the treatment. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (55)

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

Medical University of Vienna,
Verified postcode
Vienna, Austria· Suspended
Klinikum Wels-Grieskirchen GmbH
Verified postcode
Wels, Austria· Recruiting
OLV Ziekenhuis Aalst
Verified postcode
Aalst, Belgium· Active not recruiting
CHU Saint Pierre Brussels
Verified postcode
Brussels, Belgium· Active not recruiting
UCL St Luc
Verified postcode
Brussels, Belgium· Active not recruiting
Clinique CHS MontLégia
Verified postcode
Liège, Belgium· Active not recruiting
CHU Grenoble Alpes - Hôpital Michallon
Verified postcode
Grenoble, France· Active not recruiting
CHU Bordeaux Hôpital St. André
Verified postcode
Bordeaux, France· Active not recruiting
Assistance Publique Hôpitaux de Marseille (AP-HM)
Verified postcode
Marseille, France· Withdrawn
HEGP (Hôpital Européen Georges Pompidouv) Paris
Verified postcode
Paris, France· Recruiting
Centre Hospitalier de Pau
Verified postcode
Pau, France· Active not recruiting
Krankenhaus Maria Hilf Bad Neuenahr-Ahrweiler
Verified postcode
Ahrweiler, Germany· Suspended

Common questions

What is renal denervation?

It's a medical procedure using sound waves to treat certain nerves near your kidneys, aiming to help lower high blood pressure.

Am I being given a new experimental treatment?

No, the Paradise Ultrasound System is already an approved treatment. This study is just observing how well it works long-term in real patients.

What extra things will I need to do if I join?

You'll be asked to take home blood pressure readings and complete questionnaires about your quality of life, alongside your usual care.

Will this study affect my usual high blood pressure treatment?

No, you will continue with your regular medical care and treatments as prescribed by your doctor.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without it affecting your medical care.

How to find out more

Helen Reeve-Stoffer, PhD

hreeve-stoffer@recormedical.com +44 (0) 794 774 8006 Official trial record

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