Atrial Fibrillation Clinical Trial
— POTTEROfficial title:
World-wide Survey on the Incidence, Diagnosis and Prognosis of Atrio-oesophageal Fistula Following Percutaneous Catheter Ablation
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | February 28, 2024 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Atrio-oesophageal fistula after Ablation - Indication for AF ablation as per current guidelines - Performing the ablation at an ablation centre Exclusion Criteria: - No Atrio-oesophageal fistula after Ablation |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Luebeck | Dr.Ahmad Keelani |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 5 year | |
Secondary | Diagnosis and management of AOF | Evaluating the diagnosis and management of the AOF | 5 year | |
Secondary | Mortality rate | Analysis of the mortality rate | 5 year |
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