What is this study about?

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Understanding Atrial Fibrillation

Atrial fibrillation (AF) is a heart condition where the heartbeat is irregular and often too fast. This happens when the upper chambers of the heart (the atria) beat out of sync with the lower chambers (the ventricles). If AF is not treated, it can raise the risk of stroke, heart failure, or other serious problems, and can cause blood clots to form in the heart.

Because of these risks, it’s important to treat AF, especially if it happens often or doesn’t go away on its own. One common treatment is called catheter ablation. In this procedure, a doctor places a thin, flexible tube (catheter) into a blood vessel and guides it to the heart. Energy is then delivered to make small scars in heart tissue. These scars block the faulty signals that cause the heart to beat irregularly.

What Happens During Ablation

The most common area targeted during ablation is near the veins that bring oxygen-rich blood from the lungs to the heart, called the pulmonary veins. This is known as pulmonary vein isolation (PVI).

While ablation can help many patients, AF sometimes comes back, and people may need the procedure again. Usually, doctors repeat the same treatment in the pulmonary veins. These veins contain muscle fibers that are known to be potent triggers of atrial fibrillation.

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What This Study Is Testing

This study is testing whether adding treatment to another area of the heart, called the posterior wall, can lead to better results. The posterior wall has been shown to trigger or maintain atrial fibrillation so that if electrically isolated, fibrillation may subside. Patients in the study will be placed into one of two groups:

1

One group will receive ablation in the pulmonary veins only (redo PVI).

2

The other group will receive ablation in both the pulmonary veins and the posterior wall (redo PVI + PWI).

By comparing these two groups, the study aims to determine whether treating both areas helps reduce AF and improve quality of life more effectively than treating the pulmonary veins alone.

Regardless of which group you’re placed in, you will continue having regular follow-up visits with your cardiologist over the course of four years, aligning with the traditional standard of care.
In addition to these regular visits, there are a few study-specific items you will be asked to perform:
  • Complete a questionnaire about your symptoms and overall quality of life
  • Wear a small ECG patch on your chest for about one week at different points during the follow-up period so doctors can monitor heart rhythm

Who can join this study?

You can talk to your doctor about joining the study if:

You are 18 years or older

You have received one prior PVI ablation procedure for persistent AF

You have recurrent AF despite prior ablation

You are eligible for repeat ablation procedure

You are willing to comply with all post-procedural follow-up requirements and to sign informed consent

There are other things to consider as well. Only you and your doctor can decide if this study is right for you.

Registry

During your repeat ablation procedure, your doctor will first perform cardiac mapping. This test checks whether your atrial fibrillation may be coming back because the abnormal connection between the left atrium and the pulmonary vein has re-formed.

If this connection is found, you will stay in the randomized portion of the study and continue as planned. If the connection is not found, you will not take part in the randomization portion. Instead, you will receive a different ablation procedure as determined by your ablation doctor. Even if you are not randomized, you will still be followed in the same way as other participants.

 

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Benefits and Risks

Potential Benefits

Reduction in AF symptoms

Improvement in quality of life

Fewer clinical complications and lesser need for unscheduled medical care

Information learned from study may help others in the future

Potential Risks

Risks associated with PVI and PWI ablation procedures

Risks associated with cardiac mapping procedure

Risk of privacy being compromised (breach of confidentiality)

Risk of minor skin irritation from the adhesive patch used during 7-day ECG 

Other risks that are currently unknown

Frequently asked questions

Contact Us


601 Elmwood Ave,
Rochester, NY
14642


repeataf.mail@urmc.rochester.edu


Your participation can help future generations


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