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New heart-zapping technique tested to improve irregular heartbeat treatment

NCT ID NCT05986526

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Updated 2 times

Summary

This study tests whether adding extra ablation to the back wall of the heart's left atrium improves outcomes for people with persistent atrial fibrillation (a type of irregular heartbeat). About 206 participants will receive either standard vein isolation or vein isolation plus back-wall ablation using a newer, safer energy method called pulsed-field ablation. The goal is to see which approach better prevents heart rhythm problems over one 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

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

206 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Feb 2028

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: 1. Persistent atrial fibrillation documented on a 12 lead ECG, Holter monitor or implantable cardiac device within last 2 years of enrollment 2. Persistent atrial fibrillation is defined as a sustained episode lasting \> 7 days 3. Candidate for ablation based on current atrial fibrillation guidelines 4. Continuous anticoagulation with Vitamin-K-Antagonists or a NOAC for ≥4 weeks prior to the ablation; or a transesophageal echocardiography and/or CT scan that excludes left atrial thrombus ≤48 hours before the ablation procedure 5. Age of 18 years or older on the date of informed consent 6. Signed informed consent Exclusion Criteria: 1. Previous left atrial ablation or left atrial surgery 2. Left atrial diameter \>60 mm in the parasternal long axis 3. Patients with paroxysmal atrial fibrillation 4. Patients with persistent atrial fibrillation lasting \>3 years 5. AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery) 6. Intracardiac thrombus 7. Pre-existing pulmonary vein stenosis or pulmonary vein stent 8. Pre-existing hemidiaphragmatic paralysis 9. Contraindication to anticoagulation or radiocontrast materials 10. Prior mitral valve surgery 11. Severe mitral regurgitation or moderate/severe mitral stenosis 12. Myocardial infarction during the 3-month period preceding the consent date 13. Ongoing triple antithrombotic/anticoagulation therapy 14. Cardiac surgery during the 3-month interval preceding the informed consent date or scheduled cardiac surgery/ transcatheter aortic valve implantation 15. Significant congenital heart defect (including atrial septal defects or pulmonary vein abnormalities but not including a patent foramen ovale) 16. NYHA class III or IV congestive heart failure 17. Left ventricular ejection fraction (LVEF) \<35% 18. Hypertrophic cardiomyopathy (wall thickness \>1.5 cm) 19. Significant chronic kidney disease (eGFR \<30 ml/min) 20. Uncontrolled hyperthyroidism 21. Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding the informed consent date 22. Ongoing systemic infections 23. History of cryoglobulinemia 24. Cardiac amyloidosis 25. Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women \< 50 years before inclusion) 26. Life expectancy less than one year per physician opinion 27. Currently participating in any other clinical trial, which may confound the results of this trial 28. Unwilling or unable to comply fully with the 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

  • Cantonal Hospital Baden

    Baden, Switzerland

  • Cantonal Hospital St. Gallen

    Sankt Gallen, Switzerland

  • Inselspital, University Hospital Bern

    Bern, 3010, Switzerland

  • University Hospital Basel

    Basel, Switzerland

  • University Hospital Lausanne

    Lausanne, 1011, Switzerland

  • University Hospital Zürich

    Zurich, Switzerland

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