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Study on Early Treatment of Persistent Atrial Fibrillation: Comparing Cryoballoon Therapy with Dronedarone, Flecainide, Sotalol, and Propafenone in Symptomatic Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Persistent Atrial Fibrillation (AF), a condition where the heart beats irregularly and often rapidly. The study compares two different approaches to managing this condition. One approach involves a procedure called cryoablation, which uses a special tool called a Cryoballoon to freeze and isolate the areas of the heart that trigger AF. The other approach uses medications known as antiarrhythmic drugs (AAD) to help control the heart's rhythm. The medications being studied include Dronedarone, Flecainide, Sotalol, and Propafenone.

The purpose of the study is to determine if early treatment with cryoablation is more effective than using antiarrhythmic drugs in preventing the recurrence of irregular heartbeats. Participants in the study will be randomly assigned to receive either the cryoablation procedure or one of the antiarrhythmic medications. The study will monitor participants over a period of time to see how well each treatment works in reducing episodes of irregular heartbeats and improving overall heart health.

Throughout the study, participants will have regular check-ups to assess their heart rhythm and overall health. The study aims to provide valuable information on the best first-line treatment strategy for managing Persistent Atrial Fibrillation, potentially leading to improved outcomes for patients with this condition. The study will also look at other factors such as healthcare costs, quality of life, and any side effects related to the treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing your medical history and conducting necessary tests such as an ECG or Holter monitor to document episodes of atrial fibrillation (AF).

  2. Step 2

    Randomization

    You will be randomly assigned to one of two groups: the cryoablation group or the antiarrhythmic medication group. This process ensures that each participant has an equal chance of being placed in either group.

  3. Step 3

    Treatment initiation

    If assigned to the cryoablation group, a procedure will be scheduled to isolate the pulmonary veins using a cryoballoon. This is a minimally invasive procedure aimed at preventing AF recurrences.

    If assigned to the medication group, you will begin taking one of the following antiarrhythmic drugs: dronedarone, flecainide, sotalol, or propafenone. These medications are taken orally, and the specific dosage and frequency will be determined by your healthcare provider.

  4. Step 4

    Monitoring period

    For the first 3 months, known as the blanking period, your heart rhythm will be closely monitored. This period allows your body to adjust to the treatment, and any AF episodes during this time will not be counted towards the study's primary outcomes.

  5. Step 5

    Follow-up assessments

    Regular follow-up visits will be scheduled at 12, 24, and 36 months to assess your heart rhythm and overall health. These visits will include tests such as ECGs and possibly Holter monitoring to check for any AF recurrences.

    Your quality of life, symptoms, and any side effects will also be evaluated using questionnaires and clinical assessments.

  6. Step 6

    End of study

    The study will conclude after 36 months. At this point, a final assessment will be conducted to evaluate the long-term effects of the treatment on your heart rhythm and overall health.

Who can join the trial?

5 criteria

  • You must have **persistent symptomatic atrial fibrillation**. This means you have a type of irregular heartbeat that causes symptoms and doesn't go away on its own.
  • You should have had at least 2 episodes of this condition in the last 24 months. Each episode should have lasted less than 12 months.
  • The most recent episode must have occurred within the last 6 months, and at least one episode should be recorded on an **ECG** (a test that records the electrical activity of your heart) or a **Holter monitor** (a portable device that records your heart's activity for 24 hours or more).
  • You must be between the ages of 18 and 75.
  • You should be a candidate for **rhythm control therapy**. This means you are suitable for treatments aimed at maintaining a normal heart rhythm, such as **AF ablation** (a procedure to destroy small areas of heart tissue causing the irregular heartbeat) or **antiarrhythmic drugs** (medications to help control your heart rhythm).

Who cannot join the trial?

8 criteria

  • Patients who have other heart conditions that are not related to atrial fibrillation (a type of irregular heartbeat).
  • Patients who have had previous heart surgeries or procedures that might affect the study results.
  • Patients who are currently using certain medications that could interfere with the study treatment.
  • Patients with severe health issues that could make participation risky, such as serious lung or kidney problems.
  • Patients who are pregnant or planning to become pregnant during the study period.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
  • Patients who have a history of substance abuse that could affect their ability to participate in the study.
  • Patients who are participating in another clinical trial that could interfere with this study.
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Investigated drugs

  • Arctic Front Cryoballoon

    is a medical device used in a procedure called cryoablation. This therapy involves using extreme cold to freeze and destroy abnormal heart tissue that causes irregular heartbeats, specifically in the treatment of atrial fibrillation. The goal is to isolate the pulmonary veins, which are often the source of erratic electrical signals in the heart, to prevent them from causing further irregular heart rhythms.

  • Antiarrhythmic Drugs (AAD)

    are medications used to treat irregular heartbeats, known as arrhythmias. These drugs work by altering the electrical signals in the heart to help maintain a normal rhythm. In this trial, antiarrhythmic drugs are being compared to the cryoablation procedure to see which is more effective in preventing the recurrence of atrial fibrillation, a common type of irregular heartbeat.

What is already known about the treatment

  • Antiarrhythmic Drugs (AAD)

    Antiarrhythmic drugs are typically taken orally and are used to manage irregular heartbeats, specifically for conditions like persistent symptomatic atrial fibrillation. These medications are well-established in medical practice and literature as a standard treatment option for controlling heart rhythm. They work by altering the electrical signals in the heart to maintain a regular heartbeat. Antiarrhythmic drugs are classified under the pharmacological category of antiarrhythmics, which are medications designed to treat abnormal heart rhythms.

  • Arctic Front Cryoballoon

    The Arctic Front cryoballoon is a medical device used in a procedure called cryoablation, which is performed by inserting a catheter through a vein to reach the heart. This device is currently being studied for its effectiveness in treating persistent atrial fibrillation by isolating the pulmonary veins to prevent irregular heartbeats. The cryoballoon works by freezing the heart tissue responsible for the abnormal electrical signals, thereby restoring normal rhythm. It is considered an interventional therapy and is being evaluated for its potential benefits over traditional antiarrhythmic drugs.

Investigated diseases

Persistent symptomatic atrial fibrillation – This condition is characterized by an irregular and often rapid heart rate that can lead to poor blood flow. It occurs when the heart's upper chambers (atria) experience chaotic electrical signals, causing them to quiver instead of contracting effectively. Over time, this can lead to symptoms such as heart palpitations, shortness of breath, and fatigue. The condition is termed "persistent" because it lasts longer than seven days and may require medical intervention to restore normal rhythm. As the disease progresses, it can lead to more severe forms of atrial fibrillation, such as longstanding persistent or permanent atrial fibrillation. The progression can also result in increased atrial arrhythmia burden, affecting the overall heart function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505962-28-00Protocol codeCryoStopPersAFEstimated enrolment226 patientsSponsorGottsegen National Cardiovascular Center

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