RecruitingOBSERVATIONAL

Tracking Results of Ablations to Combat AF Registry Generation 2

The TRAC-AF study is tracking the results of operations that treat atrial fibrillation, a common condition causing an irregular heartbeat. It's looking at how safe and effective specific surgical methods and devices are in real-world patients. Doctors are gathering information on different types of heart surgery, including procedures that involve removing small parts of the heart tissue (ablation) or closing off a small part of the heart called the LAA. This study helps doctors understand how well these procedures work over time and if there are any issues. Patients are followed for up to ten years using their regular hospital appointments, so there are no extra visits just for the study.

At a glance

Status

Recruiting

Sponsor

AtriCure, Inc.

Enrolment target

10,000

Start

01 Feb 2013

Estimated completion

01 Jan 2030

Atrial Fibrillation

What is this study about?

This study, called TRAC-AF, is designed to understand how well certain heart operations for atrial fibrillation (an irregular heartbeat) work in the real world. Atrial fibrillation can make your heart beat too fast, too slow, or unevenly, which can make you feel tired, dizzy, or breathless. The operations in this study aim to correct these irregular heartbeats using special medical devices.

The main goal is to collect information on the safety and effectiveness of these treatments. This includes looking at procedures where doctors carefully destroy tiny areas of heart tissue that cause the irregular beats (this is called ablation). Some procedures are done during open-heart surgery, while others are less invasive. The study also looks at procedures that involve closing off a small pouch in the heart called the left atrial appendage (LAA), which can help reduce the risk of blood clots.

By following many patients over a long period, up to ten years, doctors hope to learn valuable information. This will help them improve how they treat atrial fibrillation in the future and make sure patients get the best possible care. The study is gathering information from hospitals in many countries, including the UK, to get a broad picture of how these treatments work.

Key takeaways

The study tracks how well heart operations for atrial fibrillation work long-term.
It collects information from your normal hospital care for up to 10 years.
There are no extra appointments or procedures just for the study.
Your information helps doctors improve future treatments for others.
You must be 18 or older and having a specific type of heart procedure.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To be part of this study, you must be 18 years old or older, or at least the legal age in your country to agree to join a study. You must also be scheduled to have, or have already had, one of the heart operations that the study is interested in – these are procedures to treat atrial fibrillation.

Before you join, you need to be willing to give your informed consent. This means a doctor or nurse will explain the study to you fully, and you'll have the chance to ask questions. Only after you understand everything and agree, will you be able to participate.

You wouldn't be able to join if your doctor thinks there are other medical, social, or psychological reasons that would make it difficult for you to understand the study, agree to participate, or follow the regular care plan. This is to make sure the study is a good fit for you and you're comfortable with it.

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 18 years old or older?
Are you scheduled for, or have you already had, a heart procedure for atrial fibrillation?
Are you willing to discuss and sign an informed consent form?
Does your doctor believe you can understand and follow the study's requirements (which are just your normal care)?
Are you comfortable with the study accessing your routine medical records?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement is quite straightforward. You won't have any extra visits to the hospital or need any additional medical procedures beyond what your doctor would normally recommend for your care. The study will simply collect information from your routine follow-up appointments and medical records for up to ten years after your heart procedure. This means you will continue with your standard medical care as usual, and the study will use that information. There are no extra demands on your time or changes to your treatment plan just for the study.

Potential risks and benefits

Participating in this study itself doesn't involve any new risks, as it only collects information from your standard medical care. However, any heart procedure, like the ones being studied, always carries some risks, which your doctor will explain to you thoroughly before your operation. The main benefit of joining is that the information gathered from your experience, along with many others, will help doctors better understand and improve treatments for atrial fibrillation in the future. You are always free to change your mind and withdraw from the study at any time without it affecting your medical care.

Locations (28)

Huntsville Hospital
Verified postcode
Huntsville, United States· Recruiting
St. Bernards Medical Center
Verified postcode
Jonesboro, United States· Recruiting
CHI St. Vincent Heart Institute
Verified postcode
Little Rock, United States· Recruiting
Loma Linda University Medical Center
Verified postcode
Loma Linda, United States· Recruiting
Adventist Heart Institute (St. Helena Hospital)
Verified postcode
St. Helena, United States· Recruiting
Valley View Hospital
Verified postcode
Glenwood Springs, United States· Recruiting
MedStar Washington Hospital
Verified postcode
Washington D.C., United States· Recruiting
Delray Medical Center
Verified postcode
Delray Beach, United States· Recruiting
University of Florida
Verified postcode
Gainesville, United States· Recruiting
Orlando Health Heart & Vascular Institute
Verified postcode
Orlando, United States· Recruiting
St. Joseph's Hospital (BayCare)
Verified postcode
Tampa, United States· Recruiting
Franciscan Health
Verified postcode
Indianapolis, United States· Recruiting

Common questions

What is atrial fibrillation?

Atrial fibrillation is a common heart condition that causes an irregular and often rapid heartbeat. It can make you feel tired or out of breath.

What kind of treatments are being looked at in this study?

The study is looking at different types of heart operations, including those that use special devices to correct irregular heart rhythms (ablation) and procedures to close a part of the heart called the LAA.

Do I have to do anything extra if I join?

No, you don't. The study will just gather information from your usual hospital visits and medical records for up to ten years after your procedure. There are no extra tests or appointments.

Will my personal information be kept private?

Yes, any information collected will be kept private and handled according to strict rules to protect your identity.

Can I leave the study once I've joined?

Yes, you can choose to leave the study at any time, and this will not affect the medical care you receive.

How to find out more

Jarrod Goodarz, BA

jgoodarz@atricure.com 609-331-6621 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.