What is this study about?

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 cause blood clots to form in the heart. These clots can raise the risk of stroke, heart failure, or other serious problems.

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. Heat or cold energy is then used to make small scars in heart tissue. These scars block the faulty signals that cause the heart to beat irregularly.

The most common area targeted during ablation is near the veins that bring 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.

This study is testing whether adding treatment to another area of the heart, called the posterior wall, can lead to better results. Patients in the study will be placed into one of two groups:

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

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

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 or persistent 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.

What will happen if I join?

As discussed above, if you join the study you will be placed into one of two groups. Both groups will undergo a catheter ablation procedure, with one group receiving it in both the pulmonary veins and the posterior wall (PVI + PWI), and the other group receiving it in the pulmonary veins only (PVI).

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 complete. You will be asked to fill out a questionnaire regarding your symptoms and overall quality of life, and you will be asked to wear a small ECG patch on your chest for about a week at different times during the follow-up period. The patch records your heart’s rhythm so doctors can monitor it over a longer period of time.

Registry

During your repeat ablation procedure, your doctor will first do a test called cardiac mapping. This test checks whether your atrial fibrillation is coming back because the abnormal connection between the left atrium and the pulmonary vein has grown back.

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

In addition to this, your information will be entered into a registry so researchers can track how well the standard treatment works for people who don’t have the left atrium–pulmonary vein reconnection.

Benefits and Risks

Potential Benefits

Reduction in AF symptoms

Improvement in quality of life

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 on 7-day ECG patch

May be other risks that are currently unknown

Frequently asked questions

In total, 630 participants.

Contact Us


601 Elmwood Ave,
Rochester, NY
14642


contempicd.mail@heart.rochester.edu


Your participation can help future generations


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