Active not recruitingNAINTERVENTIONAL

SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

This study, called SPYRAL AFFIRM, is investigating a treatment for high blood pressure where medication alone isn't enough. It uses a special device called Symplicity Spyral for a procedure called renal denervation (RDN). RDN aims to help lower blood pressure by calming overactive nerves in the kidneys. The main goal is to check how safe and effective this treatment is over a long period. Researchers will also collect information from people who participated in previous Symplicity Spyral studies. This research is important for people with high blood pressure, and those with related conditions like heart disease or kidney problems, to find new ways to manage their health.

At a glance

Status

Active not recruiting

Phase

Sponsor

Medtronic Vascular

Enrolment target

1,899

Start

20 Oct 2021

Estimated completion

30 Nov 2029

Hypertension Vascular Diseases Cardiovascular Diseases Chronic Kidney Diseases Diabetes Mellitus

What is this study about?

This study is called SPYRAL AFFIRM, and it's looking at a new way to help people whose high blood pressure (hypertension) isn't well controlled, even with medication. The treatment being studied is called renal denervation, or RDN. It involves a procedure using a special device called Symplicity Spyral, which works by calming down certain nerves in your kidneys that can contribute to high blood pressure. The idea is that by reducing the activity of these nerves, your blood pressure might come down.

The main purpose of this study is to see how safe this Symplicity Spyral RDN treatment is, how well it works to lower blood pressure, and how long its effects last over a long period. Researchers will be carefully checking participants' health and blood pressure over time. They are also gathering extra information from people who have been part of similar Symplicity Spyral studies in the past.

Controlling high blood pressure is really important because it can lead to serious health problems like heart attacks, strokes, and kidney disease. This research is important because it could offer a new option for people who struggle to get their blood pressure under control, potentially improving their long-term health.

Key takeaways

This study is testing a new way to treat high blood pressure called renal denervation.
It uses a device called Symplicity Spyral to calm kidney nerves.
The main goal is to check safety and how well it lowers blood pressure long-term.
It's for people whose high blood pressure is difficult to control.
Participation involves a procedure and regular health check-ups.

Who may be eligible?

To be considered for this study, you would generally need to have high blood pressure that isn't well controlled. Specifically, your blood pressure readings, taken both at the doctor's surgery and at home, would need to be consistently elevated above certain levels. You must be at least 18 years old, and the study is open to both men and women.

There are also some reasons why you might not be able to join. For example, if you've already had a similar kidney nerve treatment, or if your kidney arteries aren't suitable for the procedure. You also wouldn't be able to participate if you have certain health conditions, such as severe kidney disease, a history of fainting due to low blood pressure, or if you need constant oxygen support.

Also, if you are pregnant, breastfeeding, or planning to become pregnant, you wouldn't be able to take part. People with certain types of diabetes or lung conditions might also not be eligible.

Quick self-check

Is my blood pressure consistently high, even with medication?
Do my doctor's office blood pressure readings show numbers of 140/90 or higher?
Am I at least 18 years old?
Do I have any severe kidney problems or other serious health conditions?
Am I pregnant or planning to become pregnant?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would undergo the renal denervation procedure using the Symplicity Spyral device. After the procedure, you would have regular check-ups at the hospital or clinic. These visits would involve having your blood pressure taken, blood and urine tests, and possibly other tests to monitor your heart and kidney health. The study focuses on monitoring your health and blood pressure over a long period to see how effective and safe the treatment is. The exact number of visits and the total duration aren't specified but are designed for long-term follow-up.

Potential risks and benefits

Taking part in a study like this means you might be one of the first to benefit from a new treatment that could lower your blood pressure more effectively. This could reduce your risk of serious health complications. However, like any medical procedure, there are potential risks, such as bleeding, infection, or other complications related to the procedure itself, and not everyone experiences the same benefits. You will be fully informed of all known risks before making a decision, and you always have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (100)

University of Alabama at Birmingham (UAB) Hospital
Birmingham, United States
Banner Heart Hospital
Mesa, United States
Abrazo Arizona Heart Hospital/Biltmore Cardiology
Phoenix, United States
HonorHealth Research Institute
Scottsdale, United States
Arkansas Cardiology
Little Rock, United States
Scripps Memorial Hospital
La Jolla, United States
University of California, San Francisco
San Francisco, United States
Stanford Hospital and Clinics
Stanford, United States
University of Colorado Anschutz Medical Campus
Aurora, United States
Colorado Heart and Vascular PC
Lakewood, United States
Hartford Hospital
Hartford, United States
MedStar Washington Hospital Center
Washington D.C., United States

+88 more sites — see the official record for the full list.

Common questions

What is renal denervation?

It's a procedure that uses a special device to calm down overactive nerves in your kidneys, which can help lower blood pressure.

Why is this study important?

It's important because it could lead to a new treatment option for people whose high blood pressure isn't controlled by medication alone.

Will I still need to take my blood pressure medication?

The study aims to see how this treatment affects blood pressure. Your doctors will discuss your medication plan with you throughout the study.

How long will I need to be in the study?

This study is designed for long-term follow-up to check the treatment's safety and how long its effects last.

Is the procedure painful?

The procedure is done under local anaesthetic or light sedation. Doctors will ensure you are as comfortable as possible during and after.