Paid clinical study for patients with

High
Blood Pressure

We are recruiting patients diagnosed with high blood pressure for the SPYRAL AFFIRM clinical study. This study investigates a procedure that may help patients lower their blood pressure without additional blood pressure medications.
Take the Survey
>
Take a short survey now to see if you qualify to join this study.

The SPYRAL AFFIRM Study

The SPYRAL AFFIRM study evaluates the effectiveness, safety, and long-term effects of a high blood pressure procedure using The Symplicity Spyral™ Renal Denervation System.
The procedure may be a good fit for individuals who:

  • Demographic information: You may provide us with demographic information such as your name, gender, age.
  • Contact Information: You may provide us with contact information such as email address, phone number, and postal address
  • Information about your health: You may provide us with information relating to your medical condition and diagnosis. This includes answers to questions about your symptoms, prescription information, treatment history, family health history, diagnosis, and other relevant information pertaining to your health.
  • Health insurance information: You may provide us with information about your health insurance coverage.
  • Tracking: Our servers collect information from you, including your browser type, operating system, Internet Protocol (IP) address (a number that is automatically assigned to your computer when you use the Internet, which may vary from session to session), domain name, and/or a date/time stamp for your visit.
Take the Survey
>

What are the
risks of high blood pressure?

Over time, high blood pressure may damage your arteries and make it harder to pump blood and oxygen to your heart and throughout the body.
This increases the risk of complications like stroke, heart attack, heart disease, and kidney disease.

High blood pressure was the primary or contributing cause of death for over 600,00 people in the United States in 2020.2 It is important to treat high blood pressure, even if you don’t have symptoms.

20%

lower risk of cardiovascular events

28%

lower risk of heart failure

27%

lower risk of stroke

What is renal denervation?

Renal denervation targets overactive nerves in the kidney arteries. Nerves in the kidney arteries play an important role in blood pressure management, but they can become overactive in some individuals.

Renal denervation stops overactive nerve signals that can raise blood pressure.

After renal denervation, individuals may experience lower blood pressure without additional medication. Some individuals are able to stop their hypertension medications entirely.

Qualify for the SPYRAL AFFIRM Study

An advanced, minimally-invasive treatment is now available to help lower blood pressure. This procedure targets specific nerves near the kidneys that can become overactive and cause high blood pressure

Renal denervation stops overactive nerve signals that can raise blood pressure.

After renal denervation, individuals may experience lower blood pressure without additional medication. Some individuals are able to stop their hypertension medications entirely.

Take the Survey
>

The SPYRAL High Blood Pressure Procedure

The SPYRAL AFFIRM study evaluates the effectiveness, safety, and long-term effects of a high blood pressure procedure using The Symplicity Spyral™ Renal Denervation System. The procedure may be a good fit for individuals who:

  • Are interested in a procedure that may lower blood pressure without medications
  • Want to learn more about an option that may reduce health risks associated with uncontrolled high blood pressure
  • Want to help advance science for patients diagnosed with high blood pressure
Take the Survey
>

Qualify for the SPYRAL AFFIRM Study

We are looking for patients who meet the following criteria:

  • Age 18+
  • Have been diagnosed with hypertension by their healthcare provider
  • Have a baseline office systolic blood pressure ≥140 mmHg
  • Are willing to undergo a medical procedure that may require a short hospital stay
  • Are willing to perform at-home blood pressure readings daily for 7-14 days at a time, several times a year
Take the Survey
>

Participating Clinical Study Centers

Research on the SPYRAL Procedure

The Symplicity Spyral™ Renal Denervation System is a minimally invasive procedure performed by a skilled healthcare professional. The procedure is conducted under general anesthesia and typically involves an overnight stay in the hospital for monitoring.

During the procedure, a surgeon inserts a thin tube called a catheter into the arteries leading to the kidneys. When the catheter is in place, the surgeon delivers targeted radiofrequency energy to disable overactive nerves in the arteries lining the kidneys. The catheter is then removed and nothing remains in the body after the procedure.

Take the Survey
>

Learn more about the SPYRAL AFFIRM study

Frequently Asked Questions

What are the steps to join the study?

This study involves 8 visits, including the renal denervation procedure. The study lasts for 36 months (3 years). It involves an in-hospital procedure, several office visits to assess blood pressure and lab work, at-home blood pressure monitoring, and additional medical imaging at various points in the study.

Is the high blood pressure procedure safe?

More than 20,000 people have undergone the Symplicity Spyral renal denervation procedure worldwide. During a recent three-year study, there were zero device or procedural safety events related to the procedure. In addition, renal denervation has not been shown to impact kidney function.

Is there compensation?

Patients will also be reimbursed for their time, travel, and other expenses up to $XXX. In addition, all costs for the procedure and related care are covered by the study.

Will I still need to take medication?

In previous clinical studies, participants demonstrated an average 16 mmHg reduction in systolic blood pressure after three years.(citation3) Your individual results may vary.
You should continue taking prescribed medications as directed by your doctor. Your doctor will let you know if and when you can stop taking your blood pressure medications.

Please contact our study support specialists if you have any further questions at [phone number].

Treatment for High Blood Pressure

Hypertension affects 47% (116 million) of people in the United States.2 Common treatments for high blood pressure include lifestyle changes and medications.

Reduce salt intake
Increase exercise
Healthy diet
Stop Smoking
Weight Management
Medications
Stress management
Reduce alcohol intake

1. Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. The Lancet. 2016;387:957-67.
2. Centers for Disease Control. Facts about hypertension. Accessed July 21, 2022.3. Medtronic data on file.