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NCT04377594Active, not recruiting

Ablation of Fibrotic Areas in Patients With Persistent Atrial Fibrillation.

Individually DEsigned Ablation of Low Voltage Areas in Patients With Persistent Atrial Fibrillation, a Randomized Controlled Multicenter Trial

Source: ClinicalTrials.gov · Last updated 3 Sept 2026

Brief summary (registry, in English)

Brief summary: The objective of this study is to compare two different ablation strategies in participants with persistent atrial fibrillation and fibrotic areas in the left atrium. The participant will be randomized to pulmonary vein isolation or pulmonary vein isolation plus ablation of fibrotic areas.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
23 Apr 2020
Start date
20 May 2020
Primary completion date
10 Apr 2026
Lead sponsor
Karolinska University Hospital
NCT number
NCT04377594

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 20 May 2020 to the primary completion date, 10 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • LA dimension \>55 mm as determined by an echocardiography within the previous year
  • Prior surgical or percutaneous AF ablation procedure or atrioventricular-nodal ablation

Other illness

  • Acute coronary syndrome or coronary artery bypass surgery within 12 weeks
  • Severe aortic or mitral valvular heart disease using the ESC guidelines
  • Congenital heart disease
  • Medical condition likely to limit survival to \< 1 year
  • New York Heart Association (NYHA) class IV heart failure symptoms
  • Renal failure requiring dialysis
  • History of non-compliance to medical therapy

Other

  • Contraindication to oral anticoagulation
  • AF due to reversible cause
  • Pregnant and fertile women without anticonception
  • Unable or unwilling to provide informed consent

Who the study is looking for

  • ECG-documented persistent or long-standing persistent atrial fibrillation according to European Society of Cardiology (ESC) definition
  • Symptoms e. g. palpitations, dyspnea, tiredness that is due to the atrial fibrillation.
  • Suitable candidate for catheter ablation.
  • Tried one or more antiarrhythmic drugs or unwilling to try antiarrhythmic drugs
  • Age ≥18 years.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Karolinska University Hospital
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.