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AFIB Patient Abstract

STUDY TITLE: SURGICAL ABLATION VERSUS NO SURGICAL ABLATION FOR PATIENTS WITH PERSISTENT OR LONGSTANDING PERSISTENT ATRIAL FIBRILLATION UNDERGOING MITRAL VALVE SURGERY

CURRENT STATUS: Enrollment Complete

What is the purpose of this research?
The purpose of the research is to determine whether treating atrial fibrillation with surgical ablation during scheduled mitral valve surgery is better than mitral valve surgery by itself without the surgical ablation. Surgical ablation of atrial fibrillation is a technique used by surgeons to deaden atrial heart tissue and block electrical signals that may be causing the heart to beat irregularly. There are no new procedures being tested in this study: both mitral valve surgery and surgical ablation are regularly performed in patients who have mitral valve problems and atrial fibrillation. What is not known with certainty, is whether patients with atrial fibrillation which has been difficult to treat with medication alone, would do better having surgical ablation in addition to mitral valve surgery, or just having mitral valve surgery alone.

Who can be in this study?
People who have mitral valve disease requiring surgery and atrial fibrillation may take part in this research study. The study will be conducted in 10 major medical centers in the United States and Canada the plan is to enroll 260 patients in total.

Who cannot be in this study?
Some reasons a person may not be able to participate in this research study include: previous catheter ablation for atrial fibrillation, active infection, uncontrolled hypo- or hyperthyroidism, or contraindication for anticoagulation therapy.

Why is this study necessary?
We know that atrial fibrillation is associated with a higher risk for stroke and heart disease. Though surgical ablation of atrial fibrillation is a common procedure during mitral valve surgery, there is no conclusive proof that it is better than having mitral valve surgery alone. Atrial fibrillation will go away in some patients after mitral valve surgery alone. As such, we do not know whether or not surgical ablation adds any additional benefit to mitral valve surgery alone, and a well planned research study will help us answer this question.

What procedures will be followed?
Once you have decided to participate in the study and signed an informed consent document, the study will proceed in the following stages.

You will be asked to have an electrocardiogram (ECG) to confirm that you have atrial fibrillation. If you have atrial fibrillation and are eligible to participate, we will schedule you for a physical exam and blood tests that will give us information about your general health. We will ask you questions about your past medical history and about the medications you are taking. We will also ask you to complete questionnaires about your quality of life.

The assignment to receive surgical ablation or not will occur while you are in the operating room for your planned mitral valve surgery, using a process called random assignment (which is much like a flipping a coin). If you are assigned to receive surgical ablation, random assignment will also be used to determine whether the ablation will be performed in just your left atrium, or in both your left and right atriums. The chance that you will be selected to receive surgical ablation during your planned mitral valve surgery is 50%. You will be notified about whether or not you underwent surgical ablation in addition to the planned mitral valve surgery after your operation is over.

Mitral valve surgery and surgical ablation (for those assigned to this treatment) will be performed using standard surgical techniques. All patients will be treated the same after surgery.

You will be prescribed antiarrhythmic medications after surgery and will continue to take them by mouth for 3 months. If at any point you are still having atrial fibrillation, your drug dosage may be adjusted. It is important that only one doctor prescribe and control the dosage of your antiarrhythmic medication. At 3 months the medication will be stopped and the study team will communicate with your primary physician or cardiologist. You will be on an anti-coagulant (often called a blood thinner) for at least one year. This will require taking medications on a daily basis, as well as periodic blood tests, ordered by your doctor, to adjust the medication dose. If you are still in atrial fibrillation at the end of the study you may need to remain on it after the study ends.

We will monitor your heart rhythm through a device that sends an ECG tracing over the telephone. This is called transtelephonic monitoring. The heart monitoring device will be provided to you before your hospital discharge, and the study coordinator will show you how to use it and how to transmit your heart rhythm information over the telephone. This does not require a visit to the doctor. You will also be asked to monitor your heart rhythm for 90 seconds each week and keep a diary that the coordinator will tell you how to fill out. Heart rhythm monitoring and filling out your diary will need to be done one time per week from the time of hospital discharge to the end of the study at 12 months after surgery.

In addition, you will be followed by telephone at 3, 6, 9, 18, and 24 months. We will ask you questions about changes in your medications and in your general medical condition, including any hospitalizations

At 6 and 12 months after your surgery, you will be asked to wear a monitor that continuously records your heart rhythm for 3 days (72 hours). This monitor is called a Holter Monitor, and the devices are now small enough that once the device is properly placed, you can go about your day and may not even notice that your heart rhythm is being monitored.

At 12 months after the surgery, all patients, regardless of whether they received surgical ablation or not, will be asked to return for an outpatient evaluation to the hospital where they had their surgery, or to their own cardiologist’s office. At this evaluation, you will be asked what medications you have been taking, given an echocardiogram, and asked to fill out some quality of life questionnaires.

All of your hospital charges will be collected from the hospital for the duration of the study. All de-identified financial data collected prior to, during, and after the surgery will be sent to the data coordinating center at Mount Sinai School of Medicine for storage and analysis.

What are the possible risks of being in this study?
The research involves approved surgical procedures. The health risks for you are the same whether you have these procedures as a participant in the research study or outside of the research study.

As your doctor will explain to you when you sign the informed consent form for the surgery, in addition to the health risks associated with the planned mitral valve surgery, there are some risks associated with surgical ablation itself. These include damage to the heart’s electrical system (10% likelihood) or nearby tissues (less than 1%), unintended burns (less than 1%) and pulmonary vein damage (less than 1%). Furthermore, patients who are assigned to surgical ablation in both the left and right atriums will also have longer operative times.

What are the possible benefits of being in this study?
You may or may not receive personal (direct) benefit from taking part in this study. The possible benefits of taking part in this study include close monitoring by an experienced team, and the results of this study should provide important information for the medical treatment for future patients with heart conditions similar to yours.

How long will I be in the study?
If you choose to participate in the study, the expected time period during which you would be involved in the study would be 2 years.

What are the costs to be in this study?
Taking part in this study will not involve additional costs to you. All study specific tests will be paid for by the study sponsor. You and/or your insurance company will have to pay for any costs that are part of your regular medical care. Anything not paid by your health insurance will be billed directly to you for payment.

You will not receive any compensation for your participation in this research study. You will receive a fixed amount of travel reimbursement to cover local travel expenses for your participation in study follow-up visits.

Who is funding this research?This research is being supported by a research grant from the following government programs:
•  National Heart, Lung, and Blood Institute (NHLBI)
•  National Institute of Neurological Disorders and Stroke (NINDS)
•  Canadian Institutes of Health Research (CIHR)
•  Portions of the Principal Investigator and his/her research team’s salaries are being paid by this grant.

For any additional questions, you may send an email to the Mount Sinai Coordinating Center:
•  Ellen Moquete, RN, BSN, ellen.moquete@mountsinai.org, 212-659-9651 or
•  Karen O'Sullivan, MPH, karen.o'sullivan@mountsinai.org, 212-659-9720

For more information about this study, please visit
http://clinicaltrials.gov/ct2/show/NCT00903370

GCO# 08-1078(4); Current annual IRB approval period: 3/26/17 - 3/25/18

Principal Investigator: Annetine C. Gelijns, PhD