Active not recruitingOBSERVATIONAL

ADVENT Post Approval Study

This study is called ADVENT and it's looking at a treatment for a common heart condition called paroxysmal atrial fibrillation (PAF), where your heart beats irregularly. The treatment uses something called the FARAPULSE™ Pulsed Field Ablation System. Doctors want to see how safe and effective this treatment is over a long period when used for the first time in patients with PAF. This isn't a new experimental drug, but a study to observe how a known treatment works in real-world settings. It's happening in different hospitals worldwide and aims to gather more information to ensure the best care for patients.

At a glance

Status

Active not recruiting

Sponsor

Boston Scientific Corporation

Enrolment target

228

Start

25 Sep 2024

Estimated completion

01 Oct 2029

Paroxysmal Atrial Fibrillation

What is this study about?

This study, called ADVENT, is designed to keep a close eye on how well a treatment called the FARAPULSE™ Pulsed Field Ablation System works for people who have a heart condition called paroxysmal atrial fibrillation (PAF). PAF means your heart sometimes beats irregularly, which can make you feel dizzy, tired, or have a fluttering in your chest.

The FARAPULSE system is a treatment used to fix these irregular heartbeats. It works by targeting specific areas in your heart to help it beat normally again. This particular study isn't testing if the treatment works; that's already known. Instead, it's observing how safe and effective it is over a long period when doctors use it in their usual practice for patients who are having this treatment for the first time.

The main goal is to understand the long-term effects of the FARAPULSE system. Gathering this real-world information helps doctors and researchers learn more about how to best help patients with PAF, ensuring the treatment continues to be safe and effective for many years to come.

Key takeaways

This study is observing an existing heart treatment called FARAPULSE for irregular heartbeats.
It aims to understand the long-term safety and effectiveness of this treatment in real-world use.
Participants must have specific types of irregular heartbeat (PAF) that haven't responded to medication.
It involves regular check-ups and monitoring after the treatment.
You can withdraw from the study at any time.
The study helps improve future care for patients with atrial fibrillation.

Who may be eligible?

To be considered for this study, you would typically need to have paroxysmal atrial fibrillation (PAF) that hasn't responded well to medication, or if you couldn't take certain heart rhythm medicines. This treatment would also need to be something your doctor recommends for you using the FARAPULSE system.

You must also be able to understand and agree to take part in the study, and be willing to come for all the necessary check-ups and follow-up appointments. You need to be an adult of legal age to give your consent.

There are also some reasons why you might not be able to join. For example, if you've already had a similar heart procedure before, or if you have other heart problems that might need a different kind of treatment. Pregnant women or those planning to become pregnant are also typically excluded, as are individuals with a very short life expectancy.

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.

Do I have paroxysmal atrial fibrillation (PAF) that hasn't responded to medication or for which I couldn't take certain drugs?
Has my doctor recommended the FARAPULSE treatment for me?
Am I an adult and able to understand and agree to participate?
Am I willing and able to attend all necessary follow-up appointments?
Have I previously had a similar heart procedure called left atrium (LA) ablation?

Answer every question to see your result.

What does participation involve?

If you decide to take part, doctors will use the FARAPULSE system to treat your heart condition. After the procedure, you'll have regular follow-up visits to check how you're doing and see how well the treatment is working. This will involve appointments over a long period, typically several years. You might also have a small heart monitor inserted, called a LUX-Dx, if you don't already have one. This helps doctors keep track of your heart rhythm continuously during the study.

Potential risks and benefits

Taking part in this study means doctors will closely monitor your treatment with the FARAPULSE system. The potential benefit is that your heart rhythm may improve, and you'll be contributing to valuable information that helps many other patients in the future. As with any medical procedure, there are always some potential risks, which your doctor will discuss in detail with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (30)

Mobile Infirmary Medical Center
Verified postcode
Mobile, United States
Scottsdale Healthcare - Shea
Verified postcode
Scottsdale, United States
Alta Bates Summit Medical Center
Verified postcode
Oakland, United States
Washington Hospital Center
Verified postcode
Washington D.C., United States
Florida Heart Rhythm Specialists, PLLC
Verified postcode
Fort Lauderdale, United States
Baptist Medical Center
Verified postcode
Jacksonville, United States
Mount Sinai Medical Center
Verified postcode
Miami Beach, United States
Tallahassee Memorial Hospital
Verified postcode
Tallahassee, United States
AdventHealth Tampa
Verified postcode
Tampa, United States
Memorial Health University Medical Center
Verified postcode
Savannah, United States
Ochsner Clinic Foundation
Verified postcode
New Orleans, United States
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States

Common questions

What is paroxysmal atrial fibrillation (PAF)?

PAF is a heart condition where your heart sometimes beats irregularly and quickly for short periods, and then goes back to a normal rhythm.

What is the FARAPULSE system?

It's a medical device used in a procedure to help correct irregular heart rhythms in people with atrial fibrillation.

Is this a brand new treatment being tested?

No, the FARAPULSE system is already in use. This study is observing its long-term safety and how well it works in regular care.

How long will the study last if I join?

The study aims to follow patients for a long time to see the long-term effects, often several years.

What if I change my mind after joining?

You can leave the study at any time without having to give a reason, and it won't affect your future medical care.