Active not recruitingOBSERVATIONAL

STOP Persistent AF PAS

This study, called STOP Persistent AF PAS, is looking at how well a treatment called cryoablation works for people who have persistent atrial fibrillation, which is an irregular and often fast heartbeat. This treatment uses very cold temperatures to block faulty electrical signals in the heart that cause the irregular rhythm. The study is especially focused on a specific type of catheter (a thin, flexible tube) used in this procedure. It's a global study, following patients over three years to see how they are doing and if the treatment remains safe and effective in the long run. It's a routine follow-up required after the treatment device was approved for use in the US, making sure its performance is checked in real-world use.

At a glance

Status

Active not recruiting

Sponsor

Medtronic Cardiac Ablation Solutions

Enrolment target

400

Start

19 Aug 2021

Estimated completion

01 Jul 2028

Persistent Atrial Fibrillation

What is this study about?

Imagine your heart has a built-in electrical system that tells it when to beat. If this system goes a bit haywire, it can cause your heart to beat irregularly and sometimes very quickly. This is called Atrial Fibrillation, or AF for short. When it's 'persistent,' it means your heart stays in this irregular rhythm for a long time unless doctors intervene.

One way doctors can try to fix this is with a procedure called cryoablation. This involves using a special tube (called a catheter) that's guided into your heart. Once there, it applies very cold temperatures to tiny areas of heart tissue. This cold helps to 'freeze' and block the faulty electrical signals that are making your heart beat irregularly, helping it return to a normal rhythm.

This particular study, called the STOP Persistent AF PAS, is following up on people who have had this cryoablation procedure using a specific type of catheter system (the Arctic Front™ Cardiac Cryoablation Catheter System). It's an important study because it helps doctors understand how well this treatment works over a longer period – specifically for three years – after it's been used in patients. It also looks at the safety of the procedure in real-world settings. This type of ongoing check is often required by health authorities, like the US Food and Drug Administration, to make sure medical devices continue to perform as expected after they've been approved for wider use.

Key takeaways

It's a study looking at long-term results for cryoablation for persistent irregular heartbeats.
It observes patients who have had a specific cryoablation procedure.
The study lasts for three years to check safety and how well the treatment works over time.
It's a follow-up required after the cryoablation device was approved for use.
Helps doctors understand performance of the treatment in real-world settings.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with persistent atrial fibrillation, which means your irregular heartbeat has been ongoing. You must also be 18 years of age or older.

An important part of joining is that you are scheduled to have a cryoablation procedure using a particular set of catheters (the Arctic Front™ system) and that you are willing to follow the study's requirements and give your permission to participate.

You wouldn't be able to join if you've already had a similar heart ablation procedure before (except for a specific type of ablation for a different heart rhythm issue). Also, you can't be in another study at the same time unless it has been specifically approved for you to do so.

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.

I have been diagnosed with persistent atrial fibrillation.
I am 18 years old or older.
I am planning to have a cryoablation procedure using the Arctic Front™ system.
I have not had a previous heart ablation (except for a specific type for AFL).
I am willing to follow the study's instructions and consent to participate.

Answer every question to see your result.

What does participation involve?

If you join this study, your journey will involve getting the cryoablation procedure as planned. Following the procedure, the study team will keep in touch with you for up to three years. This follow-up will involve regular check-ups and assessments to see how you are doing, how your heart rhythm is, and to monitor for any side effects or issues. The study aims to gather information over this three-year period to understand the long-term effects of the treatment. There are no specific medications provided by the study, as it's observing the standard treatment you'd receive. You'll be asked to come to study visits as planned over these three years.

Potential risks and benefits

Participating in this study helps doctors understand more about the long-term effectiveness and safety of cryoablation for persistent atrial fibrillation. This knowledge can improve care for future patients. As with any medical procedure, there are potential risks associated with cryoablation itself, which your doctor will explain in detail. The study is observational, meaning it's watching what happens after a treatment you would receive anyway. You are free to withdraw from the study at any time without affecting your medical care.

Locations (17)

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

Hartford Hospital
Verified postcode
Hartford, United States
Cardiology Associates of Fairfield County
Verified postcode
Stamford, United States
BayCare Medical Group Cardiology
Verified postcode
Clearwater, United States
Heart Rhythms Solutions
Verified postcode
Davie, United States
Carle Foundation Hospital
Verified postcode
Urbana, United States
Henry Ford Heart & Vascular
Verified postcode
Detroit, United States
Spectrum Health Hospitals
Verified postcode
Grand Rapids, United States
The Lindner Research Center
Verified postcode
Cincinnati, United States
Texas Cardiac Arrhythmia Research Foundation
Verified postcode
Austin, United States
Texas Health Research & Education Institute
Verified postcode
Dallas, United States
Kepler Universitätsklinikum Med Campus III.
Verified postcode
Linz, Austria
St. Vinzenz-Hospital Köln
Verified postcode
Cologne, Germany

Common questions

What is 'persistent atrial fibrillation'?

It's a type of irregular and often fast heartbeat that lasts for a long time unless doctors intervene to correct it.

What is cryoablation?

It's a procedure that uses very cold temperatures to freeze and block faulty electrical signals in the heart that cause an irregular rhythm.

Why is this study happening?

This study is a required follow-up to see how well a specific cryoablation system works and how safe it is over several years, after it has been approved for use.

How long will I be followed in the study?

If you participate, you will be followed for a period of three years after your cryoablation procedure.

Will I get any special treatment in this study?

No, this study observes patients who are receiving a standard cryoablation procedure. It doesn't involve any new or experimental treatments, just close follow-up.