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

September 16, 2024 updated by: Roland Richard Tilz, MD, University of Luebeck

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • Klinik für Rhythmologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing PVI and developing an AOF

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of AOF following percutaneous catheter ablation
Time Frame: 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
5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis and management of AOF
Time Frame: 5 year
Evaluating the diagnosis and management of the AOF
5 year
Mortality rate
Time Frame: 5 year
Analysis of the mortality rate
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Collaborators

Dr.Ahmad Keelani

Investigators

  • Principal Investigator: Roland R Tilz, Universitaet Luebeck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

February 21, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Potter AF Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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