RecruitingOBSERVATIONAL

PulseSelect™ PFA Global Registry

This study is called the PulseSelect™ PFA Global Registry. It's looking at a new treatment for atrial fibrillation, which is a common condition causing an irregular and often fast heart rate. The study isn't testing a new, unproven device; the PulseSelect™ PFA system is already approved for use. Researchers are simply observing how patients who receive this treatment as part of their standard care are doing. They will collect information on how safe and effective the treatment is in a large number of patients in different hospitals around the world. Patients will be followed for at least 12 months after their procedure.

At a glance

Status

Recruiting

Sponsor

Medtronic Cardiac Ablation Solutions

Enrolment target

1,950

Start

23 Jul 2024

Estimated completion

01 Jul 2027

Atrial Fibrillation

What is this study about?

You might have come across this study if you or someone you know has atrial fibrillation, a condition where the heart beats irregularly. This study, called the PulseSelect™ PFA Global Registry, is designed to gather real-world information about a specific treatment for this condition called the PulseSelect™ PFA System.

Think of it like this: once a new treatment or device is approved for use, doctors like to keep a close eye on how it performs in a wider group of patients in everyday hospital settings. This study isn't a trial of a brand-new, experimental treatment; the PulseSelect™ PFA System is already approved and available. Instead, it's an observational study, which means doctors are simply observing and collecting data from patients who are receiving this treatment as part of their usual care.

The main goal is to understand more about how safe and effective the PulseSelect™ PFA System is when used in many different people across various hospitals globally. By collecting this information, healthcare professionals can continue to learn and improve care for people with atrial fibrillation.

Key takeaways

Tests an approved treatment for atrial fibrillation.
Observational study, not a clinical trial of a new drug.
Aims to collect real-world safety and effectiveness data.
Participation involves routine care and follow-up.
Data collected will help understand the treatment better for future patients.
You can withdraw at any time.

Who may be eligible?

To take part in this study, you would generally need to be at least 18 years old and have a diagnosis of atrial fibrillation. Crucially, your doctors must have already decided that the planned treatment for you will involve using the PulseSelect™ PFA System. You also need to be willing to follow the study's requirements and provide your informed consent, which means you understand what's involved and agree to participate voluntarily.

There are a few reasons why you might not be able to join. For example, if you're already taking part in another clinical study, you might not be eligible. Also, certain local laws or hospital rules could affect who can participate. The study team will check all these details carefully 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.

Am I at least 18 years old?
Do I have atrial fibrillation?
Has my doctor planned for me to have treatment using the PulseSelect™ PFA System?
Am I willing to follow the study requirements and give my consent?
Am I not currently involved in another clinical study that would prevent my participation?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part in this study, your atrial fibrillation treatment using the PulseSelect™ PFA System will be carried out just as it would be normally, following your hospital's standard procedures. There won't be any extra procedures specifically for the study at the time of your treatment.

After your procedure, you will have follow-up appointments and assessments that align with what your doctor would typically recommend. The study will arrange to collect information from these routine appointments. The researchers will follow your progress for at least 12 months to see how you are doing over time. This means attending your regular appointments and allowing the study to collect information from them.

Potential risks and benefits

Because this study uses a treatment that is already approved and part of standard care, the potential benefits and risks are generally the same as those associated with the PulseSelect™ PFA procedure itself, which your doctor will explain to you thoroughly. The main benefit of participating in the study is that the information gathered from your experience will help improve understanding of the treatment for future patients. There are no additional medical risks from being in the study, as it's observational. You are free to withdraw from the study at any time without it affecting the quality of your medical care.

Locations (37)

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

Vancouver General Hospital
Verified postcode
Vancouver, Canada· Recruiting
McGill University Health Centre (MUHC)
Verified postcode
Montreal, Canada· Recruiting
Fuwai Hospital Chinese Academy of Medical Sciences
Verified postcode
Beijing, China· Recruiting
Fujian Provincial Hospital
Verified postcode
Fuzhou, China· Recruiting
The Second Affiliated Hospital of Harbin Medical University
Verified postcode
Harbin, China· Recruiting
Nanjing Drum Tower Hospital
Verified postcode
Nanjing, China· Recruiting
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Verified postcode
Shanghai, China· Recruiting
Fuwai Shenzhen Hospital Chinese Academy of Medical Sciences
Verified postcode
Shenzhen, China· Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Verified postcode
Ürümqi, China· Recruiting
Wuhan Asia General Hospital
Verified postcode
Wuhan, China· Recruiting
The First Affiliated Hospital of Xiamen University
Verified postcode
Xiamen, China· Recruiting
Klinička Bolnica Dubrava
Verified postcode
Zagreb, Croatia· Recruiting

Common questions

What is atrial fibrillation?

Atrial fibrillation is a common heart condition that causes an irregular and often abnormally fast heart rate.

Is the PulseSelect™ PFA system new?

The PulseSelect™ PFA system is an approved medical device; this study is observing its use in real-world settings rather than testing a new product.

Do I get special treatment in this study?

No, your treatment will be carried out according to your hospital's usual practice for this procedure. The study simply collects information about it.

How long will I be followed?

You will be followed for at least 12 months after your procedure as part of this study, aligning with routine follow-up.

Can I leave the study if I change my mind?

Yes, you can choose to withdraw from the study at any time. This will not affect your medical care.

How to find out more

Josman Suri

josman.suri@medtronic.com 7635050262 Official trial record

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