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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05273645
Other study ID # Potter AF Study
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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