New heart-zapping technique tested to improve irregular heartbeat treatment
NCT ID NCT05986526
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 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: 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Persistent atrial fibrillation are added.
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
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can zapping the heart beat drugs for AF in heart failure?
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Extra vein ablation tested to keep persistent AFib from returning
- Duel of ablation catheters: which wins for persistent AF?
- Can a new drug stop long atrial fibrillation episodes?
- Which ablation method wins for tough atrial fibrillation cases?