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RecruitingNAINTERVENTIONAL

A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

This study is investigating a new treatment for an irregular heartbeat called atrial fibrillation, specifically for people who experience it occasionally (paroxysmal) or constantly (persistent). The treatment uses a device called the Globe Pulsed Field System. It works by gently isolating specific areas within the heart to correct the irregular rhythm. Researchers want to find out if this method, which combines isolating the lung veins with isolating certain scarred areas, is both safe and effective over 12 months. This trial is for people who have tried and not been able to tolerate or benefit from at least one other heart rhythm medication.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Kardium Inc.
Enrolment target
115
Start
10 Jun 2025
Estimated completion
01 Jun 2028

What is this study about?

You might be reading this because you or someone you know has atrial fibrillation, which is a condition where your heart beats irregularly. This can cause symptoms like feeling tired, out of breath, or having heart palpitations. While there are treatments available, sometimes they don't work for everyone, or people can't tolerate the side effects.

This study is looking at a new way to treat atrial fibrillation using a special system called the Globe Pulsed Field System. This system delivers gentle electrical pulses to specific areas in the heart. The idea is to create tiny barriers that stop the rogue electrical signals causing the irregular heartbeat, helping your heart find a more normal rhythm. The treatment involves two parts: isolating the pulmonary veins, and also treating any scarred areas that might be contributing to the problem. The main goal is to see if this new approach is safe and whether it keeps your heart rhythm steady for at least a year.

This research is important because it could offer a new option for people with atrial fibrillation, especially if current medications haven't worked well for them. By studying how safe and effective this treatment is, doctors hope to improve care for people living with this common heart condition.

Key takeaways

  • Exploring a new treatment for irregular heartbeats (atrial fibrillation).
  • Uses gentle electrical pulses (Globe Pulsed Field System) to correct heart rhythm.
  • For people whose current heart medicines haven't worked well.
  • Aims to check safety and effectiveness over one year.
  • Could offer a new option for managing atrial fibrillation symptoms.

Who may be eligible?

To join this study, you would need to have been diagnosed with atrial fibrillation that causes symptoms, whether it comes and goes (paroxysmal) or is constant (persistent). You should also have tried at least one antiarrhythmic medication (a type of heart rhythm drug) that either didn't work for you or caused side effects that you couldn't tolerate.

There are also some reasons why you might not be able to join. For example, if your atrial fibrillation has been constant for more than a year, or if it's caused by something else that can be fixed, like a thyroid problem. You also wouldn't be able to participate if you've had a blood clot or stroke recently, or if you've had major heart procedures in the last few months. If you have another heart device implanted, such as a pacemaker, or if your heart muscle is significantly weakened, you also couldn't join. There are also limits on body weight and the size of your heart's upper chamber.

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.

  1. Do I have atrial fibrillation that causes symptoms?
  2. Has my atrial fibrillation been constant for less than a year?
  3. Have I tried at least one heart rhythm medication that didn't help or I couldn't tolerate?
  4. Have I had no major heart events (like a heart attack or stroke) recently?
  5. Do I not have an existing heart device like a pacemaker?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo the treatment using the Globe Pulsed Field System. Your safety and how well the treatment is working would be monitored closely for 12 months. This would involve a series of follow-up appointments and checks at the clinic. These appointments would likely include physical exams, heart rhythm recordings (like ECGs), and possibly blood tests to make sure you're doing well. You would also be asked about any symptoms you're experiencing. The total duration of your active participation in the study, including the procedure and all follow-up, would be at least one year.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive access to a new treatment for atrial fibrillation that could improve your symptoms and quality of life, especially if other medications haven't helped. However, as with any medical procedure, there are potential risks, such as bleeding, infection, or other complications related to the heart procedure. The research team will explain all known risks and monitor you closely. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

  • Westpfalz-Klinikum GmbH Kaiserslautern
    Verified postcode
    Kaiserslautern, Germany· Recruiting

Common questions

What exactly is atrial fibrillation?

It's a common condition where the heart's upper chambers beat irregularly and often too fast, leading to an uneven heartbeat.

What is the Globe Pulsed Field System?

It's a new system that uses gentle electrical pulses to stop irregular heart signals and help the heart beat normally.

How long will I be in the study if I join?

You will be followed for 12 months after the procedure to check on your progress and the treatment's effectiveness.

Will I have to stop taking my current medications?

The study team will discuss all your medications and make recommendations safely. Do not stop any medication without medical advice.

Is this a new type of treatment?

Yes, this study is evaluating a newer approach to treating atrial fibrillation with gentle electrical pulses.

How to find out more

Clinical Affairs

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Prospective Clinical Study to Evaluate the Safety and Effe…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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