Isolating the left atrial appendage during balloon ablation for atrial fibrillation
Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Luebeck Academic / other |
| Locations | 3 sites (Hamburg, Free and Hanseatic City of Hamburg and 2 other locations) |
| Trial ID | NCT04240366 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with persistent or long-standing persistent atrial fibrillation who meet the criteria for ablation.
Not a fit: Patients with paroxysmal atrial fibrillation or those with significant anatomical abnormalities may not benefit from this study.
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 performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
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 this trial is running
Hamburg, Free and Hanseatic City of Hamburg and 2 other locations
- 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
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.