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

NCT ID: NCT05273645

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-31

Study Completion Date

2024-02-28

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Atrio-Oesophageal Fistula PVI Catheter Ablation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Roland Richard Tilz, MD

Prof. Dr. med. Roland Richard Tilz

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roland R Tilz

Role: PRINCIPAL_INVESTIGATOR

Universitaet Luebeck

Locations

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Klinik für Rhythmologie

Lübeck, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Other Identifiers

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Potter AF Study

Identifier Type: -

Identifier Source: org_study_id

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