New heart ablation method could be safer, trial aims to prove
NCT ID NCT07156877
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a new pulsed field ablation (PFA) catheter to standard heat or cold ablation for atrial fibrillation (AF). About 136 adults with AF will be randomly assigned to one of the two methods. Researchers will check if the new approach is as good at preventing irregular heartbeats and if it causes fewer serious complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2028
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 or persistent atrial fibrillation documented on a 12 lead electrocardiogram or Holter monitor (lasting ≥30 seconds) within the last 24 months. * Candidate for ablation based on current AF guidelines * Continuous anticoagulation with Vitamin-K-Antagonists or a non-vitamin K antagonist anticoagulant (NOAC) for ≥4 weeks prior to the ablation; or a transesophageal echocardiogram (TEE) and/or computed tomography (CT) that excludes left atrial thrombus ≤48 hours before ablation * Age of 18 years or older on the date of consent * Informed consent as documented by signature Exclusion Criteria: * History of left atrial (LA) ablation or surgery involving the LA * Persistent atrial fibrillation (AF) lasting longer than 12 months * AF resulting from temporary or reversible causes * Presence of thrombus within the heart chambers * Prior pulmonary vein (PV) stenosis or stenting * Existing paralysis of one side of the diaphragm * Known allergy or contraindication to anticoagulant medication or contrast agents * History of mitral valve surgery * Significant mitral valve disease * Myocardial infarction occurring within three months prior to informed consent * Current use of triple antithrombotic therapy * Cardiac surgery within the past three months or a scheduled cardiac surgery or TAVI * Major congenital heart abnormalities * Congestive heart failure classified as NYHA class III or IV * Left ventricular ejection fraction (LVEF) less than 35% * Diagnosed hypertrophic cardiomyopathy (wall thickness exceeding 1.7 cm) * Severe chronic kidney disease (eGFR below 30 ml/min) * Uncontrolled hyperthyroidism * Stroke or transient ischemic attack (TIA) within three months before consent * Active systemic infections * History of cryoglobulinemia * Diagnosed cardiac amyloidosis * Current pregnancy * Estimated life expectancy under one year, as judged by the treating physician * Enrollment in another clinical study that may interfere with this trial's outcomes * Inability or unwillingness to adhere to study requirements and follow-up visits
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AZ Sint-Jan Brugge AV
RECRUITINGBruges, 8000, Belgium
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UZ Brussel
RECRUITINGJette, 1090, Belgium
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Other studies related to the condition(s) this trial covers.
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