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PrOgnosis Following Esophageal FisTula FormaTion in Pts Undergoing CathetER Ablation for AF Study (POTTER)

U

University of Luebeck

Status

Completed

Conditions

Atrial Fibrillation
PVI
Catheter Ablation
Atrio-Oesophageal Fistula

Study type

Observational

Funder types

Other

Identifiers

NCT05273645
Potter AF Study

Details and patient eligibility

About

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.

Full 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.

Enrollment

138 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Vanessa Schmidt; Ahmad Keelani

Data sourced from clinicaltrials.gov

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