An observational study in Atrial Fibrillation, Atrio-Oesophageal Fistula and PVI, sponsored by University of Luebeck. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Luebeck · Observational
Pulmonary vein isolation emerged as an effective and safe strategy to treat atrial fibrillation patients. Atrio-oesophageal fistula (AOF) represents a rare but devastating complication of AF ablation procedure. This complication (0.016-0.07%) requires an international effort to allow for better understanding of the factors contributing to its occurrence and the best management strategies. A worldwide, retrospective, multicenter registry focusing on the incidence, diagnosis and management of this complication.
Data about the incidence, optimal management and outcome of AOF is sparse. The largest national and international surveys report on less than 50 AOF. The latest worldwide survey was conducted in 2015 and managed to include 31 patients who developed AOF after atrial fibrillation ablation procedure. In the meanwhile, the total number of AF ablation procedures increased significantly. Additionally, AF ablation technology changes significantly with e.g. increasing numbers of cryoballoon ablation and contact force guided radiofrequency ablation.
The study is designed as a worldwide, multi-centre, anonymised registry study to evaluate the incidence, optimal management and outcome of this AOF. More than 50 patients with AOF following percutaneous catheter ablation will be included in the register.
3,958 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 138 is below the median of 300 across 1,390 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University of Luebeck is the lead sponsor of 76 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing PVI and developing an AOF
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Incidence of AOF following percutaneous catheter ablation
1\. Evaluating the Incidence of atrio-oesophageal fistula after percutaneous catheter ablation in patients with atrial fibrillation, as well as the more detailed analysis of the incidence of AOF after PVI with Cryo Balloon or RF Contact Force
Time frame: 5 year
Diagnosis and management of AOF
Evaluating the diagnosis and management of the AOF
Time frame: 5 year
Mortality rate
Analysis of the mortality rate
Time frame: 5 year
Plan to share: No
Ran from Mar 2022 to primary completion in Feb 2023, 10 months.
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University of Luebeck