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Atricure Synergy Ablation Lesions for Non-paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-pump Endo/Epicardial Cardiac Surgery.

IRB Number

12-597

ClinicalTrials.gov Identifier

NCT01694563

Trial Status

Open for Enrollment
Phase Post Market

Why is this study being done?

The purpose of this post-approval clinical study is to collect data from more subjects to continue to evaluate long-term safety and effectiveness of the Synergy Ablation System now that the device has been approved by the FDA.

Who is eligible to participate?

Patients who have been diagnosed with a non-paroxysmal form of atrial fibrillation (persistent or long standing persistent). Atrial Fibrillation (AF) is an irregular heartbeat, which may cause symptoms such as pounding sensations in your chest, dizziness, fatigue, chest pain, and/or shortness of breath. People may participate in this clinical research trial if their study doctor has determined that they have AF and require surgery to correct another heart problem other than AF.

What is involved?

A pre-operative screening must be done to determine whether you are eligible to enter the study. A physical assessment and blood tests will be done, a medical history will be taken and a 12 lead electrocardiogram (ECG) will be performed. A urine pregnancy test will be collected for women who are of childbearing potential. Day of surgery: A transthoracic (across the chest) Echocardiogram (TTE) probe will be used to confirm there are not clots in your atria (the upper chambers of your heart), and to assess the function and size of your heart. This procedure is an electrocardiogram that requires a probe to be inserted down your throat into the esophagus (the long tube that connects the throat to the stomach). You will be under anesthesia before this test is done. The surgeon will perform the surgical procedure for AF using standard surgical procedures. The AtriCure Synergy Ablation System will be used to apply energy until the ablation is complete. This study will include a step to make sure the surgeon places the AtriCure Synergy Ablation System on heart tissue and not the pulmonary veins (these are the veins that go from the heart to the lungs). This procedure will be done to reduce the risk of damage to the pulmonary veins. This study may also include a monitoring device during the AF surgery to see whether or not the lesions created by the AtriCure Synergy System have blocked the faulty electrical impulses that cause AF. Depending on your medical history and condition during surgery your study doctor may choose not to perform this monitoring procedure on you. The open heart surgery required to correct your other heart problem will be done. Post-Operative (prior to discharge): A complete physical assessment will be done, including any complications you may have experienced during your hospital stay. A review of all medications you have taken while in the hospital prior to discharge will be done. A 12 lead electrocardiogram (ECG) and blood tests will be done. Follow-Up Visits: Follow-up clinic appointments will be made for you at approximately 30 days, 4, 12, 24 and 36 months after surgery so that follow-up tests can be performed. If you continue to have AF, you may need to be seen more frequently. The types of medicines you are taking will be reviewed at each visit. At each visit, the following tests and assessments will be performed: 1-A review of current medicines and a review of how you are feeling (your health status) since your surgery or last follow-up visit. 2-A physical assessment, including an assessment of any illnesses, hospitalizations or other events related to your heart condition that have occurred since your discharge from the hospital or last visit to your physician. 3-Blood tests. 4-A 12 lead electrocardiogram (ECG)-performed at 30 day and 4 month follow-up only. 5-If you still have AF, you may be asked to begin taking new or different doses of current medications for the treatment of AF. You may undergo a cardioversion. Cardioversion is a procedure in which your heart is stopped (by applying electrical energy through your chest) for a very short period of time and then immediately restarted. This will sometimes stop your AF. 6-At your 12, 24, and 36 month follow-up visit after your surgery you will be asked to wear a small monitor or patch continuously for 48 hours. This is called a Holter Monitor or it could be a Zio patch. The monitor or patch will record your heart rhythm the entire time you wear it. If you have a pacemaker, the recording will be received from the pacemaker. The exact timing of this visit will be determined by your doctor and by the types of medication you are taking and how long you have been

How long is the study?

Your participation will last three years (36 months) with office visits after your surgery.

Who can I contact for additional information?

You may contact Theresa Boley, APN at (217)545-5000.

Who is the Principal Investigator of this study?

Stephen Hazelrigg, MD

Where is the trial located?

Springfield, Illinois