Ablation techniques for persistent atrial fibrillation
Individually DEsigned Ablation of Low Voltage Areas in Patients With Persistent Atrial Fibrillation, a Randomized Controlled Multicenter Trial
NA · Karolinska University Hospital · NCT04377594
This study is testing two different heart procedures to see which one helps people with persistent atrial fibrillation feel better and stay free from irregular heartbeats longer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska University Hospital (other) |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT04377594 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two different catheter ablation strategies for patients with persistent atrial fibrillation and fibrotic areas in the left atrium. Participants will be randomized to receive either pulmonary vein isolation alone or pulmonary vein isolation combined with ablation of low voltage areas. The primary goal is to assess the freedom from atrial arrhythmias after one to two ablation procedures within six months, measured at twelve months post-procedure. The study will also evaluate the overall burden of atrial arrhythmias and health-related quality of life outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with documented persistent atrial fibrillation and symptoms related to the condition.
Not a fit: Patients with severe heart conditions, significant structural heart disease, or those who have previously undergone atrial fibrillation ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with persistent atrial fibrillation, potentially reducing symptoms and improving quality of life.
How similar studies have performed: While there are non-randomized studies suggesting benefits of ablating low voltage areas, this approach has not been extensively tested in randomized trials, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (RECRUITING)
Study contacts
- Study coordinator: Nikola Drca, MD
- Email: nikola.drca@sll.se
- Phone: +46858580000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Catheter ablation, Low voltage