NAVISTAR® THERMOCOOL® Catheter for the Treatment of Atrial Fibrillation- TX

• The primary efficacy endpoint is freedom from documented symptomatic PAF episodes from days 91-361. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
• The primary safety endpoint is the incidence of early onset (within 7 days of ablation procedure) catheter-related adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

• Secondary Endpoints AF Status will be evaluated for each subject by assessing: Quality of Life (QOL) scores [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• 24-hour Holter data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• TTM data [ Time Frame: 1 year ] [ Designated as safety issue: No ]

This trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. It is currently FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory Ventricular Tachycardia for MI patients. The catheter is approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.

This is a prospective, non-randomized, multi-center trial that will enroll a maximum of 100 participants at up to 25 hospitals in North America.

We're trying to improve treatment for atrial fibrillation - you can help!

Do you have episodes of chest pain, palpitations or fainting? This may be due to a condition called "Paroxysmal Atrial Fibrillation". If drug therapy has not been successful to treat this condition or you have intolerable side effects due to medications you are currently taking to treat this condition, you may be eligible for this trial.

What is being studied?

This clinical trial is evaluating the safety and effectiveness of a non-drug treatment (medical device) called catheter ablation. This study is evaluating whether a particular investigational ablation catheter can be used safely and effectively to treat paroxysmal atrial fibrillation.

What does the treatment consist of?

In this procedure, thin flexible tubes (catheters) are inserted into a vein in the groin and threaded into the heart. An attachment at the tip of the catheter delivers electrical energy to the heart tissue. This results in a small, localized burn which modifies the areas of heart muscle.

Is this treatment dangerous?

All interventional treatments have risks. However, this procedure is widely used for other types of heart rhythm disorders in the U.S. and worldwide with low complication rates. The treatment of paroxysmal atrial fibrillation is a new indication for this particular catheter.

Why would I want to take part in this trial?

Currently in the U.S., atrial fibrillation is primarily treated with drug therapy. But about half of patients treated with antiarrhythmic drugs fail to achieve relief from atrial fibrillation or find the side effects of the drugs intolerable. The purpose of the study is to demonstrate whether catheter ablation is safe and effective for treating atrial fibrillation. You would therefore be helping to advance knowledge about the treatment of patients like yourself who have atrial fibrillation and who are either not getting relief from medications or are bothered by the drug's side effects.

• Heart Diseases
• Arrhythmia
• Atrial Fibrillation

You may be eligible to participate in this study if you have failed to respond to drug treatment for you atrial fibrillation, or find your medication intolerable.

Inclusion Criteria

• Patients with documented symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment
• Failure of at least one AAD for PAF as evidenced by recurrent symptomatic PAF, or intolerable side effects due to AAD
• Signed Patient Informed Consent Form.
• Age 18 years or older.
• Able and willing to comply with all pre-, post- and follow-up testing and requirements.

Exclusion Criteria

• Previous ablation for atrial fibrillation.
• Patients on amiodarone therapy at any time during the previous 6 months.
• CABG procedure within the last 6 months
• Documented left atrial thrombus
• Presence of implanted ICD.
• Unstable angina.
• Myocardial infarction within the previous two months.
• LVEF < 40%.
• Contraindication to anticoagulation
• Enrollment in an investigational study evaluating another device or drug.
• Uncontrolled heart failure or NYHA Class III/IV heart failure.
• Left atrial size ≥ 50 mm