Who is sponsoring this study?

The study sponsor is ProRhythm, a medical device company located in Ronkonkoma, New York. They have pioneered the application of High Intensity Focused Ultrasound (HIFU) to advance the minimally invasive treatment of complex medical conditions. www.prorhythm.com

What is Atrial Fibrillation?

Atrial Fibrillation (AF) is a type of cardiac arrhythmia. An arrhythmia is when the heartbeat becomes irregular or changes its rate inappropriately. An arrhythmia can occur for a number of reasons, but in cases of Atrial Fibrillation it happens when another part of the heart (often located at the pulmonary veins) tries to take over as the pacemaker. Many parts of the right and left upper chambers (atria) try to signal the heart to beat with rapid, irregular impulses. These impulses cause the upper chambers of the heart to contract very rapidly, often so fast that the chambers “quiver” instead of “really” pumping. This fibrillation, or rapid contracting of the atria, interrupts the heart’s normal efficient pumping.

What are the potential problems resulting
from Atrial Fibrillation?

A person with Atrial Fibrillation is three to five times more likely to have a stroke than the general population. When the quivering atria no longer pumps blood efficiently, some blood may stay in the atria with each heartbeat. The pooled blood may eventually clot, increasing the risk of stroke from a dislodged clot. About 15% of all strokes occur in people with Atrial Fibrillation.

Atrial Fibrillation may prevent the heart from pumping enough blood and oxygen to meet a person's needs. The quivering atria reduce the overall efficiency of the heart’s pumping action. The rapid ventricular heart rate fails to efficiently pump blood to the rest of the body. Patients often complain of a lack of energy and significantly reduced quality of life.

The disease incidence increases with age. As a patient grows older, the risk of Atrial Fibrillation seems to increase, especially after age 60.

What is the focusAF study?

The focusAF Study investigates the ProRhythm™ Ablation System, which uses High Intensity Focused Ultrasound (HIFU) for the treatment of certain types of Atrial Fibrillation. It is designed to compare the safety and effectiveness of the HIFU device against FDA-approved anti-arrhythmic medications.

What is HIFU?

HIFU is the process of focusing ultrasound energy into a region or pattern in order to ablate tissue. Much in the way that a magnifying glass can be used to focus sunlight into a “hot spot”, ultrasound can be focused to ablate tissue, effectively blocking the electrical activity causing the arrhythmia.

By focusing the ultrasound energy into convergent beams, heat sufficient to ablate tissue is generated at the targeted site without damaging intervening or surrounding tissue.

Is financial compensation provided and are there costs for participating in the investigational clinical research trial?

The cost of required medical tests will be billed to your insurance company in the normal way if you have the HIFU ablation or if you have a different ablation procedure. The sponsor will pay for the MRI or CT if you are randomized into the drug group, if your pulmonary veins are not the right size, or if you choose to decline treatment. Patients enrolled in this study will be compensated for their time. (a.) $25 per week for follow-up phone calls in Months 3, 4, 5 and 6 (b.) $100 per week for follow-up phone calls in Months 11 and 12

If I participate, what are the requirements?

Following treatment and discharge from the hospital, participants must be available for scheduled follow-up intervals for a period of 12 months either by telephone or office visits.

Will the device cause temporary or
long-term side effects?

As with any medical device and/or procedure, there are risks and side effects that may not be known at this time. Precautions will be taken to monitor findings during the study that may affect your willingness to continue to participate in the study. Your doctor will inform you of significant new findings that may affect your willingness to continue participation in the study.

When will I know if I am eligible?

We are only able to tell you if you’ve met the initial phone screening eligibility criteria. All final decisions regarding eligibility to participate in the clinical study are made by the study physician in your area.

How will my medical information be kept confidential?

Every effort will be made to keep all information about you private. Your name will not appear in any publications or reports about this study. If any information is sent to the study sponsor, your data will be coded with a unique number. Only the study staff at your doctor’s office will know how to connect your name to this number.

Are clinical research studies safe?

The United States government and, specifically, the Food and Drug Administration (FDA) have strict regulations and safeguards in place to protect people who choose to participate in clinical trials. The FDA must approve clinical trials that present significant patient risk. Additionally, every clinical trial in the U.S. must be reviewed and approved by an Institutional Review Board (IRB). The purpose of an IRB is to protect the rights and safety of people who volunteer to take part in research studies. Before participating in a trial, a person must agree to sign an Informed Consent Form, which provides detailed information about the study and study procedures. Experienced doctors who have been thoroughly trained are designated as investigators for the study. These investigators (doctors), who specialize in a specific condition or disease, administer the study procedures and closely monitor study participants. For more information on clinical research trials, visit: www.clinicaltrials.gov/ct/info.If you have additional questions, please call 1 (866) 351-3409. Thank you!