Early Cryoballoon Ablation Compared With Heart Rhythm Medicines in Persistent Atrial Fibrillation
Compares early cryoballoon ablation with heart rhythm medicines in adults with persistent atrial fibrillation.
Plain-language title generated from the registry record
Registry title: First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation
Key facts
- Where
- Goteborg, Karlskrona, Orebro, Umea, and Uppsala, SwedenSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with persistent atrial fibrillation who have symptoms. It compares cryoballoon ablation as first treatment with rhythm-control medicine.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Persistent symptomatic atrial fibrillation, not long-standing. At least 2 episodes in the last 24 months, the latest in the last 6 months, one recorded on a 12-lead ECG or Holter monitor.
- Earlier treatment
- People cannot have had a previous AF ablation or surgery. They cannot take class I or III rhythm drugs daily at adequate doses. Beta-blockers and pill-in-the-pocket use are allowed.
Main reasons for not taking part
- Severe heart failure (NYHA III-IV) or LVEF of 40 % or less
- Myocardial infarction, revascularisation, stroke or TIA in the last 6 months
- Hypertrophic cardiomyopathy or a severely enlarged left atrium
- Significant valve disease needing treatment, or a valve prosthesis
- Expected survival under 3 years, alcohol or drug abuse, or being in another trial
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05939076, who can take part
Where in Sweden
- Sahlgrenska University Hospital-Vastra GotalandsregionenGoteborg, SwedenTaking people
- Region BlekingeKarlskrona, SwedenTaking people
- Region Oerebro LaenOrebro, SwedenTaking people
- Region VaesterbottenUmea, SwedenTaking people
- Uppsala University HospitalUppsala, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Örebro County
- Trial code
- NCT05939076EU 2023-505962-28-00
- Record updated
- 11 July 2023
- Original description
The goal of this multicentre, prospective, randomized, open, blinded for evaluation of end point (PROBE) controlled parallel-group superiority trial, is to compare the efficacy of antiarrhythmic drug (AAD) therapy and cryoballoon pulmonary vein isolation (PVI) regarding freedom from atrial fibrillation (%) assessed by an implantable cardiac monitor (ICM), ECG tracing or Holter at 12 months in patients with persistent AF. The main question[s] it aims to answer are:Read full original descriptionShow less
First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation - a Randomized Study Comparing Early Trigger Isolation Using the Cryoballoon Versus Antiarrhythmic Medication
The goal of this multicentre, prospective, randomized, open, blinded for evaluation of end point (PROBE) controlled parallel-group superiority trial, is to compare the efficacy of antiarrhythmic drug (AAD) therapy and cryoballoon pulmonary vein isolation (PVI) regarding freedom from atrial fibrillation (%) assessed by an implantable cardiac monitor (ICM), ECG tracing or Holter at 12 months in patients with persistent AF. The main question[s] it aims to answer are:
* Will first-line cryoballoon ablation for PVI compared to AAD, result in 25 % higher freedom from atrial tachyarrhythmias lasting > 6 minutes at 12 months (primary outcome) excluding three months initial blanking period, in patients with symptomatic and recurrent persistent AF? * Will first-line cryoablation for PVI, compared to AAD result in a superior improvement in health related Quality of Life (HRQoL), AF/AT burden, AF/AT progression and reversion, more reverse atrial remodeling, cognitive function, healthcare utilization with associated costs, better safety, at 12-24-36 months as compared with drug use? Participants will be randomized 1:1 to first-line PVI using the cryoballoon or to first-line antiarrhythmic drug therapy and during 3 years follow-up undergo regular;
* Continuous ECG monitoring for assessment of first AF recurrence and AF burden using an implantable cardiac monitor, * Regular echocardiographic exams for reverse atrial remodelling assessment, * HRQoL questionnaires * Assessment of cognitive function * Atrial fibrillation evaluation regarding structured characterisation and AF progression/regression * Assessment of Health care use and costs * Safety
Inclusion: Non-longstanding persistent symptomatic AF with at least 2 episodes within last 24 months, the latest episode within the previous 6 months and one documented on a 12 lead ECG or Holter monitor, that is classified as either; Classical persistent AF (continuously sustained beyond 7 days and <12 months in duration) as defined by ESC guidelines14 OR; Persistent AF which has progressed from paroxysmal AF (patients who have been cardioverted within 7 days of onset provided a history of spontaneous conversion to sinus rhythm is lacking during the past 24 months); Candidate for rhythm control therapy; AF ablation or AAD based on symptomatic AF.
Exclusion: Previous AF ablation or surgery; Myocardial infarction, revascularisation previous 6 months; Stroke or Transient Ischemic Attack (TIA) within previous 6 months; 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; Severe heart failure (NYHA III-IV); Significant valvular disease requiring treatment or valve prothesis; Planned cardiac intervention within the next 12 months or cardiac surgery last 6 months; Reduced left ventricular ejection fraction (LVEF ≤40 % during sinus rhythm); Severe Chronic Obstructive Pulmonary Disease (COPD) stage III or chronic kidney disease (eGFR< 30 umol/l)); Regular daily use of AAD class I or III at adequate therapeutic dosages (pill-in-the-pocket permitted, beta-blockers permitted); 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; Tachycardiomyopathy; Dependent on VVI (ventricular single chamber inhibited) pacing; Participation in another trial or absence of consent.