Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New heart procedure could be safer and just as effective for AFib

NCT ID NCT05534581

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

210 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Paroxysmal atrial fibrillation are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Inselspital, Bern University Hospital

    Bern, 3010, Switzerland

  • University Hospital Basel

    Basel, 4031, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.