Active not recruitingNAINTERVENTIONAL

Esophageal Protection Study: A Multicenter Study

This research is investigating a new way to protect your food pipe (oesophagus) during an important heart procedure called AF ablation. AF ablation is used to correct an irregular heartbeat (atrial fibrillation). While effective, there's a small risk of heat damage to your oesophagus because it sits very close to where the procedure takes place. This study compares a special cooling device, called ensoETM, with the standard method of just monitoring temperature. The aim is to see if the cooling device not only reduces the risk of oesophageal injury but also helps improve the long-term success of the AF ablation. Participants will have an equal chance of receiving either the cooling device or the standard temperature monitor during their procedure.

At a glance

Status

Active not recruiting

Phase

Sponsor

Advanced Cooling Therapy LLC, d/b/a Attune Medical

Enrolment target

152

Start

10 Mar 2022

Estimated completion

31 May 2026

AF - Atrial Fibrillation Complication Atrio-Esophageal Fistula

What is this study about?

You're likely reading this because you or someone you know has atrial fibrillation (AF), which is a common condition where your heart beats irregularly and too fast. This can make you feel unwell, tired, and out of breath. A common and effective treatment for AF is a procedure called catheter ablation. During this procedure, doctors use heat energy inside the heart to correct the faulty electrical signals causing AF.

While AF ablation is generally safe, there's a small but serious risk of damage to your food pipe (oesophagus). This is because the oesophagus is located very close, just behind, the part of the heart where the treatment is applied. Current protection during the procedure involves placing a probe in your oesophagus to monitor its temperature, stopping if it gets too hot. However, this method isn't always reliable as the probe can move.

This study is looking at a newer device called ensoETM, which is designed to actively cool your oesophagus during the ablation procedure. Previous smaller studies suggest this cooling device is better at protecting the oesophagus compared to just monitoring temperature. This large study aims to confirm these promising results and see if using the cooling device also leads to better long-term success in treating AF.

Key takeaways

Investigating a new cooling device for heart ablation procedures.
Aims to protect the oesophagus from potential heat damage.
Compares the cooling device to standard temperature monitoring.
Could lead to safer AF ablation and better long-term results.
Participants have a 50/50 chance of getting either method.
Suitable for AF patients having ablation under general anaesthesia.

Who may be eligible?

This study is looking for people who have atrial fibrillation and are already scheduled to have an AF ablation procedure under a general anaesthetic. You'll need to pass the usual health checks required for this procedure.

There are a few reasons why you might not be able to join the study. For example, if you're under 18 or over 85 years old, or if your ablation procedure is planned with just local anaesthetic. Also, if you've had a similar heart ablation procedure in the last three months, or if you're currently taking part in another clinical trial that might conflict with this one, you wouldn't be able to participate.

If you decide to have an optional check-up procedure called an endoscopy as part of the study, there shouldn't be any medical reasons preventing you from having that either. The doctors will discuss all of this with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you scheduled for an AF ablation under general anaesthetic?
Are you between 18 and 85 years old?
Have you *not* had a similar heart ablation in the last 3 months?
Are you *not* currently in another clinical trial that might interfere?
Can you provide your consent to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue with your scheduled AF ablation procedure as planned. During the procedure, there's a 50/50 chance that you will receive either the new oesophageal cooling device (ensoETM) or the standard temperature monitoring probe. You won't know which one you're receiving to ensure the study results are as fair as possible. All participants will undergo the AF ablation under general anaesthesia. The study will mainly involve monitoring your protection method during the ablation and then seeing how you recover and your heart rhythm performs in the long term. The total duration of participation will depend on the standard follow-up for your AF ablation procedure, allowing researchers to gather data on long-term outcomes to understand the effectiveness of the protective methods.

Potential risks and benefits

Taking part in this study means you could potentially benefit from better protection against oesophageal injury during your AF ablation, especially if you receive the new cooling device. This could lead to a safer procedure and potentially better long-term heart rhythm control. However, like any medical procedure or study, there are potential risks, though the aim of this study is to reduce one of those risks. You will be assigned randomly to one of two groups, and there's no guarantee you'll receive the new cooling device. You are completely free to withdraw from the study at any time, without it affecting your medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

NCH Research Institute
Verified postcode
Naples, United States
Kansas City Cardiac Arrhythmia Research LLC
Verified postcode
Overland Park, United States
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States
University of Pennsylvania
Verified postcode
Philadelphia, United States
Texas Cardiac Arrhythmia Research Foundation
Verified postcode
Austin, United States
St.George's Hospital
Verified postcode
London, United Kingdom

Common questions

What is AF ablation?

It's a heart procedure that uses controlled heat to correct irregular heartbeats caused by atrial fibrillation, aiming to restore a normal rhythm.

Why is my food pipe at risk?

Your food pipe (oesophagus) sits very close to your heart, so the heat used during AF ablation can sometimes affect it. This study aims to reduce that risk.

What is the ensoETM device?

It's a special medical device that gently cools your oesophagus during the heart ablation procedure to help protect it from heat damage.

Will I know which treatment I'm receiving?

No, you won't know during the study whether you're getting the cooling device or the standard temperature monitor. This helps ensure the study results are unbiased.

Will my regular medical care be affected if I join?

No, your regular medical care for your atrial fibrillation will continue as usual. Joining the study won't change your treatment plan or options.