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First-line catheter ablation for early treatment of Persistent (ongoing unless cardioverted) Atrial Fibrillation (AF) – a randomized study comparing isolation of pulmonary veins triggering AF using a Cryoballoon versus antiarrhythmic medication.
EU CTIS ID: 2023-505962-28-00
What this study is testing
The main focus is to evaluate the impact of early interventional management of persistent AF. The primary goal is to evaluate if early pulmonary vein isolation performed with the Arctic Front cryoballoon as first-line therapy is superior to antiarrhythmic drugs (AAD) in preventing atrial arrhythmia recurrences. We hypothesized that first-line PVI using the cryoballon, at an early stage of the AF disease, will result in a 25 % reduction in any atrial tachyarrhythmia recurrence at 12 months compared to the AAD group.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Non-longstanding persistent symptomatic AF with at least 2 episodes within last 24 months (both shorter than 12 months in duration), the latest episode within the previous 6 months and, one should be documented on a 12 lead ECG or Holter monitor. a) Classical persistent AF as defined by ESC guidelines, b) Persistent AF which has progressed from paroxysmal AF (patients who have been cardioverted within 7 days of onset provided a history of spontaneous conversion of episodes to sinus rhythm is lacking in near time)
- Age 18 – 75 years
- Candidate for rhythm control therapy; AF ablation or AAD based on symptomatic AF. As an example, BMI >35 would not according to clinical praxis be a candidate for AF ablation and thereby not suitable for participation in the study.
You likely can't join if
- Regular daily use of antiarrhythmic drugs of class I or III at adequate therapeutic dosages (pill-in-the-pocket permitted, beta- blockers permitted).
- Myocardial infarction, revascularisation previous 6 months.
- Stroke or TIA within previous 6 months.
- Tachycardiomyopathy.
- Dependent on VVI pacing.
- Conventional contraindications for AF ablation including AF due to reversible causes and contraindications for both class IC and class III antiarrhythmic drugs.
See the full eligibility criteria
- Non-longstanding persistent symptomatic AF with at least 2 episodes within last 24 months (both shorter than 12 months in duration), the latest episode within the previous 6 months and, one should be documented on a 12 lead ECG or Holter monitor. a) Classical persistent AF as defined by ESC guidelines, b) Persistent AF which has progressed from paroxysmal AF (patients who have been cardioverted within 7 days of onset provided a history of spontaneous conversion of episodes to sinus rhythm is lacking in near time)
- Age 18 – 75 years
- Candidate for rhythm control therapy; AF ablation or AAD based on symptomatic AF. As an example, BMI >35 would not according to clinical praxis be a candidate for AF ablation and thereby not suitable for participation in the study.
- Regular daily use of antiarrhythmic drugs of class I or III at adequate therapeutic dosages (pill-in-the-pocket permitted, beta- blockers permitted).
- Myocardial infarction, revascularisation previous 6 months.
- Stroke or TIA within previous 6 months.
- Tachycardiomyopathy.
- Dependent on VVI pacing.
- Conventional contraindications for AF ablation including AF due to reversible causes and contraindications for both class IC and class III antiarrhythmic drugs.
- Expected survival less than 3 years, alcohol or drug abuse.
- Participation in another trial or absence of consent.
- Previous AF ablation or surgery.
- Severe heart failure (NYHA III-IV).
- Reduced left ventricular ejection fraction (LVEF ≤40 % during sinus rhythm).
- Hypertrophic cardiomyopathy (septal or posterior wall thickness >1.5 cm)
- Severely enlarged LA with left atrial volume indexed to body surface area (LAVI, ml/m2) > 48.
- Significant valvular disease requiring treatment or valve protesis.
- Severe COPD stage III or chronic kidney disease (eGFR< 30 umol/l).
- Planned cardiac intervention within the next 12 months or cardiac surgery last 6 months.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.