The focusAF Clinical Research Study

Who can participate in the clinical research study?
Participants in the study may be 18-75 years of age and meet the following requirements:

• Have experienced at least two symptomatic AF episodes in the last six months.
• Have no previous history of stroke or transient ischemic attacks (TIAs).
• Have failed or proven intolerant to at least one of the following drugs:

• Fecainide (Tambocor)
• Propafenone (Rythmol)
• Quinidine (Quinidex, Quinaglute)
• Dofetilide (Tikosyn)
• Sotalol (Betapace AF)

• The criteria listed above are not the only eligibility criteria. Only your study doctor or research nurse can determine if you meet all requirements.

Click here to see if you are a candidate for the focusAF study or call 1-866-351-3409 to speak to a nurse.

If I am accepted into this clinical research study, will I receive the HIFU treatment?

Participants will be placed randomly into one of two groups: the HIFU group or the medication (control) group. If you are placed into the control group and the drug is not effective your doctor may have you stop using the drug. You then have the option of trying another medication, undergoing the HIFU ablation procedure, undergoing another treatment, or ceasing treatment for your AF. Neither your study physician, your research nurse, nor ProRhythm™ will initially know whether you are in the HIFU or the control group.

What are the requirements for participants?

Once you have signed the consent form, you will be scheduled to have an MRI or CT, which will help determine if your pulmonary veins are the right size for this type of procedure. You will also have a Trans-thoracic echocardiogram of your chest (TTE) to evaluate the structure of your heart.

If you are randomized into the device group and meet all study entrance requirements, you will receive the catheter ablation treatment with the HIFU Ablation System for your Atrial Fibrillation. A hospital stay may be required, but will be determined by your study doctor.

If you are randomized into the drug group, you will receive either treatment with a new medication that is already approved for use by the FDA for your Atrial Fibrillation, or the dose of your current Atrial Fibrillation drug may be increased.

Your participation in this study is expected to be about fifteen (15) months. After discharge from the hospital or clinic, there will be multiple follow-ups by phone and/or visits with your study doctor.

Is there any cost for participants?

Participants in the study will receive thorough evaluations before and after the ablation procedure, including diagnostic evaluations that are not generally covered by the patient’s healthcare insurance. The study sponsor will pay for the costs of all evaluations not covered by the patient’s insurance.

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.

Where are studies being conducted?

There are clinical research study centers in:

Cleveland Clinic Foundation, Cleveland, OH
Fuqua Heart Center Piedmont Hospital, Atlanta, GA
Hospital of the University of Pennsylvania, Philadelphia, PA
Lahey Clinic Medical Center, Burlington, MA
Medical University of South Carolina, Charleston, SC
Ohio State University Medical Center, Columbus, OH
Texas Cardiac Arrhythmia Research, Austin, TX
The Johns Hopkins Hospital, Baltimore, MD
University of Oklahoma Medical Center, Oklahoma City, OK
University of Pennsylvania, Philadelphia, PA
University of Virginia, Charlottesville, VA

Are you a candidate?

Click here or call 1 (866) 351-3409 to discuss the clinical research study for this investigational ultrasound therapy.