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New ablation strategy may improve heart rhythm control in persistent AFib

NCT ID NCT04377594

Disease control Sponsor: Karolinska University Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study tests whether adding ablation of scarred heart tissue to standard pulmonary vein isolation helps people with persistent atrial fibrillation stay free of irregular heartbeats. Two hundred participants will be randomly assigned to one of two ablation procedures. The main goal is to see if the extra ablation reduces arrhythmias without needing antiarrhythmic drugs after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radio frequency ablation
What this could lead to
If successful, this could lead to a more effective ablation procedure that reduces the need for antiarrhythmic drugs in patients with persistent atrial fibrillation.
What could go wrong
This is a mid-stage trial with 200 participants, so results may not apply to all patients. The added ablation of fibrotic areas may not improve outcomes and could carry extra risks like heart tissue damage.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2020

Expected to finish

Apr 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: 1. ECG-documented persistent or long-standing persistent atrial fibrillation according to European Society of Cardiology (ESC) definition 2. Symptoms e. g. palpitations, dyspnea, tiredness that is due to the atrial fibrillation. 3. Suitable candidate for catheter ablation. 4. Tried one or more antiarrhythmic drugs or unwilling to try antiarrhythmic drugs 5. Age ≥18 years. Exclusion Criteria: 1. LA dimension \>55 mm as determined by an echocardiography within the previous year 2. Acute coronary syndrome or coronary artery bypass surgery within 12 weeks 3. Severe aortic or mitral valvular heart disease using the ESC guidelines 4. Congenital heart disease 5. Prior surgical or percutaneous AF ablation procedure or atrioventricular-nodal ablation 6. Medical condition likely to limit survival to \< 1 year 7. New York Heart Association (NYHA) class IV heart failure symptoms 8. Contraindication to oral anticoagulation 9. Renal failure requiring dialysis 10. AF due to reversible cause 11. Pregnant and fertile women without anticonception 12. History of non-compliance to medical therapy 13. Unable or unwilling to provide informed consent

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation

Contacts and locations

Locations

  • Karolinska University Hospital

    Stockholm, Stockholm County, SE-14186, Sweden

More trials for these conditions

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