This trial is closed for participation.

Struggling to control your BLOOD PRESSURE?

  • Gender Both
  • Age from 18 up to and including 75

This study offers a new approach.

 

Doctors are conducting a research study called RADIANCE II to evaluate a one-time, minimally invasive procedure which may lower your blood pressure and reduce your need for blood pressure medication. If you struggle to control your blood pressure, you may be eligible to participate.

 

What is the RADIANCE II Study?

The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in patients who are known to have hypertension. Click here for the video on The Paradise System.

 

People with high blood pressure typically have overactive renal (kidney) nerves, and it has been shown that calming these overactive nerves can help reduce blood pressure. The Paradise Renal Denervation System was designed to calm these overactive nerves through a one-time, minimally invasive procedure.

During this minimally invasive procedure called Renal Denervation, a small catheter is placed in the artery (blood vessel) supplying the kidney. Ultrasound energy (sound waves) is delivered for a few seconds to reduce the activity of the nerves. After both kidneys are treated, the catheter is removed, leaving nothing behind.

 

Who can take part?

You might be eligible for the RADIANCE II Study if:

  • You are between 18 and 75 years of age
  • You have been diagnosed with high blood pressure (hypertension)
  • You have been prescribed a blood pressure medication by a physician, and are still taking it or not

 

You will join a large number of other patients with high blood pressure from various countries who are taking part in the RADIANCE II Study.


What happens if you decide to participate?

To take part in the study, you will need to visit the clinic twice prior to the procedure and nine times after the procedure over the course of three years.

The test described below will be conducted during the course of the study (not all tests will be done at every visit):

  • Blood pressure measured when sitting and standing
  • Review of your home blood pressure measurements (excluding 12, 24 and 36 months)
  • Limited physical exam (height, weight, heart rate)
  • Questions about your health
  • Questions about any changes in your medication
  • 24-hour blood pressure measurement (ambulatory blood pressure)
  • 12-lead electrocardiogram
  • Urine and blood samples will be taken
  • MRA/CTA to assess whether your kidney anatomy is suitable for the therapy and also to allow your doctor to see any changes that may have happened to the blood vessels after the procedure
  • Questions about whether you believe you have been treated or not (this will only be asked at 2 and 6 months)

 

You will receive:

  • You will receive the study procedures at no cost to you.
  • You will be monitored closely throughout the study.
  • Compensation for your travel costs.

 

How to apply

If you would like to learn more about the study and whether you may be able to take part, please register on this website and answer the questions below. If you are eligible, one of the participating clinics will contact you to schedule an appointment and will also be happy to answer any questions you may have.

The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in patients who are known to have hypertension. Click here for the video on The Paradise System

 

The results of the previous RADIANCE-HTN are important and encouraging. The results were presented at a scientific meeting held in Paris, France on May 23rd, 2018 and the data were also published at the same time in The Lancet Journal, which is one of the most prestigious international journals in Medicine.

 

The most important information that comes from the early study results is:

  • The blood pressure of patients who were treated using the ultrasound catheter was significantly lower after the procedure than the blood pressure of patients who were not treated with this catheter.
  • Treatment with the ultrasound catheter, caused average daytime systolic blood pressure to drop by 8.5 mmHg. This drop is clinically meaningful.
  • More patients treated by renal denervation had their blood pressure normalized at 2 months without the need to add antihypertensive medications than those that were not treated
  • So far there have been no safety issues found during, and up to 2 months after the procedure

ReCor Medical is the company that designs and manufactures the Paradise® System.

Its main offices located in the Silicon Valley, in Palo Alto, near San Francisco and has its European offices in the UK (www.recormedical.com). The Paradise System has been studied in clinical trials of approximately 300 patients to date. The Paradise System is CE-marked in the EU, but is not approved in the United States.

What is a clinical study?

  • A clinical study is a scientific study of how a new or existing medicine, product, procedure or treatment works in people.
  • Through clinical studies, doctors can find new and better ways to prevent, detect, diagnose, control and treat illnesses.
  • All clinical studies are carefully monitored and regulated to ensure participant well-being.
  • Participating in a clinical study is completely voluntary and will not affect the normal standard of care you

 

What is investigational about this study?

The Paradise System is a medical device made by a company called ReCor Medical Inc., based in Palo Alto, California in the USA. The device and the treatment delivered by the device, which is known as renal denervation, are investigational in the United States because they haven’t been approved by the FDA. The device has a CE Mark which means that it has been approved for use in the European Union.

 

Has this medical device been used in people?

The Paradise System has been used in clinical studies in Europe and in the United States.  The RADIANCE-HTN Study is on-going in the US and in Europe.  Initial data from RADIANCE-HTN support the continued study of this medical device.  RADIANCE II will collect data on a larger number of patients with hypertension.   

 

How many people will be in this study and for how long?

This study will enroll up to 225 subjects. Two thirds of the subjects (150 subjects) will receive the Renal Denervation and one third (75 subjects) will not (control). You will complete your participation in this study when you have finished the 36-month follow-up visit. 

Up to 50 sites in the United States and up to 50 sites outside the USA will take part in the study.

 

What is high blood pressure?

High blood pressure is a common condition in which the pressure of your blood against your artery walls is high enough that it may eventually cause health problems, such as stroke and heart disease.

 

Some patients can keep blood pressure in a normal range using blood pressure medication. Your doctor will have already tried to keep your blood pressure normal with medication, but they may not have worked for you or you may have experienced side effects from the drugs. You may also just be interested in not taking as many drugs.  Your doctor believes that renal denervation may be an option for treating your high blood pressure. 

 

What do I need to know?

  • Your will receive the study procedures at no cost to you.
  • Your will be monitored closely throughout the study.
  • It is essential that you go to all the study appointments.
  • You can withdraw from the RADIANCE II Study at any time and for any reason. This will not affect the standard of care you receive.
  • You can talk to the study team at any time about any questions or concerns you may have.
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