Symplicity HTN-3 Clinical Trial

Caution: Investigational device. Limited by United States law to investigational use.

Important Safety Information

Talk with your doctor about potential risks associated with the procedure and study.

The primary risks of the procedure are similar to the risks of all diagnostic procedures requiring catheterization of the arteries of your body. The following are possible risks of the catheterization procedure, which includes the renal angiogram (with or without the denervation procedure):

Uncommon < 10%, temporary and not severe unless otherwise indicated

  • Nausea or vomiting
  • Complications associated with the use of any pain or anxiety medication during or after the procedure
  • Complications at catheter insertion site in the groin
    • Pain
    • Bruising
    • Hematoma (collection of blood outside a blood vessel)

Rare < 1%, temporary and not severe unless otherwise indicated

  • Heart rhythm disturbances, including bradycardia (a slowed heart rate)
  • Embolism - Formation and dislodgement of a blood clot or dislodgement of cholesterol/plaque within the blood vessel, which travels downstream into small vessels, blocking blood flow and causing temporary or permanent damage to organs in the body. Clots are known to cause heart attack, stroke, kidney damage, or threaten circulation to arms or legs and may ultimately lead to incapacitation or death.
  • Complications at catheter insertion site in the groin
    • Pseudoaneurysm (injury to the artery wall resulting in a build up of blood under the skin)
    • AV fistula (an abnormal connection or passageway between an artery and a vein)
  • Vascular complications requiring surgery
  • Perforation or dissection of a blood vessel, such as the renal artery
  • Hypotension (blood pressure too low)
  • Hypertension (blood pressure too high)
  • Complications associated with the contrast agent used during the procedure, e.g., serious allergic reaction or reduced kidney function

Very Rare < .1%

  • Complications at catheter insertion site in the groin
    • Infection
    • Significant bleeding
  • Retroperitoneal bleeding (bleeding into the abdominal space)
  • Cardiopulmonary arrest
  • Death

There are additional risks that could possibly be associated with the denervation procedure/response to treatment. These complications have not yet been quantified. These potential risks may include:

  • Pain - during or after the procedure that may require treatment with pain medications.
  • Damage to one or both kidneys and/or loss of kidney function. If severe enough, this could require dialysis.
  • Damage to the blood vessel wall or other body structures from the delivery of energy, e.g., renal artery stenosis (narrowing of blood vessel), spasm, or aneurysm (ballooning of blood vessel wall).
  • Hypertension (blood pressure too high)
  • Reduction of blood pressure too far and/or too quickly which can possibly lead to organ failure, orthostatic hypotension (dizziness upon standing), dizziness or fatigue
  • Hematuria (blood in urine)
  • Proteinuria (increased amount of protein in urine)
  • Allergic and/or adverse reaction from insertion of foreign body (i.e., catheter)
  • Electrolyte disturbances (e.g., changes in the amount of salt in blood/urine)
  • Skin burn

There are additional risks that could possibly be associated with the tests and procedures performed for the clinical study. These potential risks are described below:

There are risks related to the blood tests required for the study, e.g., excessive bleeding, fainting or light-headedness, haematoma (bruising), infection, or the requirement of multiple punctures to locate a vein to draw the sample. The amount of blood you will have drawn over the course of the study will be between 7 and 17 tablespoons, depending on your group assignment and when you were enrolled.

This research study involves exposure to a small amount of radiation. As part of everyday living, everyone is exposed to naturally occurring background radiation and receives a dose of about 2 millisievert (mSv) each year. The effective dose from the renal denervation procedure is less than 5.5 mSv. The dose from this procedure is comparable to that received from many diagnostic medical x-ray and nuclear medicine procedures. At this dose level, no harmful effects of radiation have been demonstrated, as any effect is too small to measure.

There are risks of having magnetic resonance imaging testing done. These risks include: certain medication patches can cause a skin burn, you may feel claustrophobic when having the test, in rare cases an allergic reaction to the contrast solution can occur (if the contrast solution is used). Implanted medical devices that contain metal may cause problems during an MRA exam. There is a risk of damage to your kidneys from the contrast solution that may be used.

There is a possibility of risks to an unborn child. These risks are unknown. You will be given a blood or urine test to confirm that you are not pregnant prior to the cath lab procedure. Women of childbearing potential are advised to use contraceptive methods or abstain from sexual intercourse during the course of this study to avoid becoming pregnant. If you become pregnant you should advise your treating doctor immediately. He/she will advise you on further medical attention should this be necessary.

The study may involve unknown or unforeseen side effects or complications other than those mentioned above.

If any complications occur, they may lead to repeat or prolonged hospitalization, repeat procedures, emergency surgery, other emergency procedures, or, in rare cases, death.

Although there are risks associated with participation, there will be a panel of physicians independent of the study who will monitor the safety of the study. They will be overseeing your safety and the safety of all study participants.