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

Atrial Fibrillation Clinical Trial

— POTTER  

Official title:

World-wide Survey on the Incidence, Diagnosis and Prognosis of Atrio-oesophageal Fistula Following Percutaneous Catheter Ablation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05273645
• Other study ID #: Potter AF Study
• Status: Not yet recruiting
• Start date: March 31, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2022
• Source: University of Luebeck
• Contact: Vanessa Schmidt
• Phone: +49451500
• Email: vanessa.schmidt[@]uksh.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Catheter Ablation
• Esophageal Fistula
• Fistula
• PVI

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Luebeck	Dr.Ahmad Keelani

Outcome

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