New heart procedure could be safer and just as effective for AFib
NCT ID NCT05534581
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two ways to treat a heart condition called atrial fibrillation (AFib) that causes an irregular heartbeat. The standard method uses freezing (cryoballoon), while the newer method uses electrical pulses (pulsed field ablation). The goal is to see if the new method is just as good at preventing AFib from coming back, and if it has fewer side effects. About 210 adults with AFib will take part, and their heart rhythms will be monitored for a year.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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210 people
The number who actually took part.
- Started
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Sep 2022
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Paroxysmal atrial fibrillation documented on a 12 lead ECG or Holter monitor (lasting ≥30 seconds) within the last 24 months. According to current guidelines, paroxysmal is defined as any AF that converts to sinus rhythm within 7 days either spontaneously or by pharmacological or electrical cardioversion * Candidate for ablation based on current AF guidelines * Continuous anticoagulation with Vitamin-K-Antagonists or a novel oral anticoagulant for ≥4 weeks prior to the ablation; or a transesophageal echocardiography and/or computer tomography that excludes left atrial (LA) thrombus ≤48 hours before ablation * Age of 18 years or older on the date of consent * Informed Consent as documented by signature Exclusion Criteria: * Previous left atrial (LA) ablation or LA surgery * AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery) * Intracardiac thrombus * Pre-existing pulmonary vein stenosis or PV stent * Pre-existing hemidiaphragmatic paralysis * Contraindication to anticoagulation or radiocontrast materials * Prior mitral valve surgery * Severe mitral regurgitation or moderate/severe mitral stenosis * Myocardial infarction during the 3-month period preceding the consent date * Ongoing triple therapy * Cardiac surgery during the three-month interval preceding the consent date or scheduled cardiac surgery/TAVI procedure * Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO) * NYHA class III or IV congestive heart failure * Left ventricular ejection fraction (LVEF) \<35% * Hypertrophic cardiomyopathy (wall thickness \>1.5 cm) * Significant chronic kidney disease (CKD; eGFR \<30 ml/min) * Uncontrolled hyperthyroidism * Cerebral ischemic event (stroke or TIA) during the six-month interval preceding the consent date * Ongoing systemic infections * History of cryoglobulinemia * Cardiac amyloidosis * Pregnancy * Life expectancy less than one (1) year per physician opinion * Currently participating in any other clinical trial, which may confound the results of this trial. * Unwilling or unable to comply fully with study procedures and follow-up.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Inselspital, Bern University Hospital
Bern, 3010, Switzerland
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University Hospital Basel
Basel, 4031, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Pulsed electric fields take aim at irregular heartbeats
- Could a bigger balloon tame the Heart's electrical chaos?
- Can a new heart ablation technique work without x-rays?
- Could a gentle sedation cocktail replace general anesthesia for heart ablation?
- Can a new freezing balloon tame a fluttering heart as well as the old one?
- Heart signals may reveal if a common AFib procedure will last