PrOgnosis Following Esophageal fisTula formaTion in Pts Undergoing cathetER Ablation for AF Study

• Conditions: Atrial Fibrillation; PVI; Atrio-Oesophageal Fistula; Catheter Ablation

• Registration Number: NCT05273645
• Lead Sponsor: University of Luebeck

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-02-21
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-10
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-22
• Study Start: 2022-03-31
• Primary Completion: 2023-02-28
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of AOF following percutaneous catheter ablation	5 year	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

Secondary Outcome Measures

Name	Time	Method
Diagnosis and management of AOF	5 year	Evaluating the diagnosis and management of the AOF
Mortality rate	5 year	Analysis of the mortality rate

Trial Locations

Locations (1)

Klinik für Rhythmologie; 🇩🇪 Luebeck, Schleswig-Holstein, Germany