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OpenTrials
Completed

NCT Number: NCT05273645

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrio-Oesophageal Fistula Cardiovascular Diseases Catheter Ablation Heart Diseases PVI Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik für Rhythmologie

Lübeck, Schleswig-Holstein, 23538, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of AOF following percutaneous catheter ablation

    Time frame: 5 year

    • 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 outcomes

  1. Diagnosis and management of AOF

    Time frame: 5 year

    Evaluating the diagnosis and management of the AOF

  2. Mortality rate

    Time frame: 5 year

    Analysis of the mortality rate

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Registry information

Official study title

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

Acronym: POTTER

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 10, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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