Isolating the left atrial appendage during balloon ablation for atrial fibrillation
Official title: Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
Run by University of Luebeck · NCT04240366 · Data updated 2026-11-12
This study is testing if adding a procedure to isolate a part of the heart during balloon ablation can help people with long-term atrial fibrillation have fewer heart rhythm problems later on.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | University of Luebeck Academic / other |
| Locations | 3 sites (Hamburg, Free and Hanseatic City of Hamburg and 2 other locations) |
| Status | Recruiting |
| Started | December 17, 2019 |
| Main results expected | June 2028 |
| Study ends | August 2028 |
| Registry record updated | August 29, 2024 |
| Trial ID | NCT04240366 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 with persistent or long-standing persistent atrial fibrillation who meet the criteria for ablation.
✕Probably not a fit
Patients with paroxysmal atrial fibrillation or those with significant anatomical abnormalities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the effects of additional left atrial appendage isolation (LAAI) during balloon ablation in patients with persistent or long-standing persistent atrial fibrillation (AF). The intervention aims to reduce the recurrence of AF within 3-12 months compared to standard balloon-based pulmonary vein isolation alone. Patients will undergo a single index ablation, followed by treatment according to established clinical guidelines. The study will also allow for repeat ablations if AF recurs after the initial procedure.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of atrial fibrillation in patients undergoing ablation.
How similar studies have gone: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained \>7 days or \>12 months, respectively) 2. Age ≥18 and ≤80 years 3. Indication for AF ablation as per current guidelines Exclusion Criteria: 1. Missing informed consent 2. LAA diameter \>25mm 10mm distant from circumflex artery assessed by TEE 3. Paroxysmal atrial fibrillation 4. Long-standing persistent atrial fibrillation with a continuous AF duration of \>4 years 5. Previous pulmonary vein isolation or MAZE surgery 6. Previous led atrial appendage closure or surgical excision 7. Left atrial diameter \>60 mm at baseline 8. Left atrial thrombus at baseline
Where it's running
-
University Hospital Eppendorf, Hamburg, Germany
Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting -
Asklepios Klinik Altona
Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting -
Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany
Lübeck, Schleswig-Holstein, Germany Recruiting
Study contacts
- Study coordinator: Roland Tilz, Prof. Dr.
- Email: roland.tilz@uksh.de
- Phone: +49451500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.