The focusAF Clinical Research Study

This study is a prospective, randomized, controlled, multicenter clinical trial to assess the safety and effectiveness of the HIFU Ablation System in the treatment of symptomatic, paroxysmal AF compared to the control of best medical therapy with FDA approved antiarrhythmic drugs (AADs for the treatment of paroxysmal AF).

Patient Eligibility

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:

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

The criteria listed above are not the only eligibility criteria. Only our study doctor or research nurse can determine if your patient meets all requirements.

Two Randomized Study Arms

At each investigational site, qualifying patients will be randomized to one of two study arms—a HIFU study arm and a medication (control) study arm.

Randomization schedules will employ a permuted-blocks design such that at the conclusion of patient accrual, both overall and at each site, there will be an approximately equal balance of subjects in the two study arms, and the study arms will be generally balanced for each of the stratification factors employed in the randomization.

Each participant will have approximately a 50/50 chance of being enrolled into either the HIFU study arm or the medication (control) study arm. The randomization schedules themselves will be concealed from the investigational sites.

HIFU Study Arm

If a patient is randomized into the HIFU study arm and meets all study entrance requirements, he/she will receive the catheter ablation treatment with the HIFU Ablation System.

Medication (Control) Study Arm

If a patient is randomized into the HIFU study arm and meets all study entrance requirements, he/she will receive the catheter ablation treatment with the HIFU Ablation System.

If a patient is randomized into the medication group and meets all study entrance requirements, he/she will receive either treatment with a new medication that is already approved for use by the FDA or the dose of the patient’s current Atrial Fibrillation drug may be increased.

If the new or increased dose of medication does not help the Atrial Fibrillation, the patient is eligible to “cross-over” and be treated with the investigational device (HIFU Ablation Catheter) providing the patient meets one of the following stringent requirements:

1. Within the first sixty (60) days after treatment, if the patient has any serious complication(s) such as life threatening heart rhythms, stroke, etc. that are a result of the use of the new drug, or

2. After the first 60 days of treatment, if the patient has at least two symptomatic episodes of Atrial Fibrillation documented with electrocardiography (ECG, electrical tracings of the heart’s activities), or

3. After the first 60 days of treatment, if the patient has any significant side effects resulting in the discontinuation of the drug. One change (decrease) in drug dose will be allowed as an attempt to mitigate any mild side effects.

Cross-over is completely voluntary and not required. The patient can be treated with alternative (non-ProRhythm) investigational or FDA approved methods instead.

Instead of being in this study, the patient has at least five choices for treatment of Atrial Fibrillation.

• Medication to suppress the Atrial Fibrillation or to slow your heart rate during Atrial Fibrillation.
• Ablation of the heart’s normal electrical system (AV node) combined with a permanent pacemaker to control the heart rate.
• Catheter ablation procedure to eliminate Atrial Fibrillation using an alternative (non-ProRhythm) investigational ablation system.
• Heart surgery to ablate the Atrial Fibrillation.
• Decline treatment at this time.

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 the patient’s insurance company in the normal way if the patient has the HIFU ablation or if he or she has a different ablation procedure. The Sponsor will pay for the MRI or CT if the patient is randomized into the HIFU study arm, if the patient’s pulmonary veins are not the right size, or if the patient chooses to decline treatment.