Prevalence and Predictors of Esophageal Thermal Lesions in High-power-Short-duration Ablation of Atrial Fibrillation

Completed

• Conditions: Esophagus Injury; Atrial Fibrillation

• Registration Number: NCT05709756
• Lead Sponsor: Helios Health Institute GmbH

Brief Summary

Patients with documented atrial fibrillation who were referred to our clinic for catheter ablation will undergo standard HPSD ablation and subsequent esophagoscopy.

After esophagoscopy patients will be followed up for one month in the form of a telephone follow-up.

The primary endpoint of the study assessed by esophagoscopy performed on the day after the index catheter ablaton is the incidence of esophageal thermal lesions.

Secondary endpoints include:

1. The size of the esophageal thermal lesions.

2. The severity of esophageal thermal lesions.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-02-02
• Primary Completion: 2023-08-01
• Study Completion: 2023-09-01
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

Inclusion Criteria

• Atrial fibrillation documented in the 12-lead ECG
• Indication for catheter ablation in accordance with currentn ESC guidelines

Exclusion Criteria

• Pregnancy
• Women of childbearing potential without a negative pregnancy test within 48 hours prior to ablation procedure
• Known intracardiac or other thrombi
• Contraindication to anticoagulation
• Contraindication to esophagoscopy: diseases and deformities of the cervical spine, esophageal varices

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of ablation-related esophageal thermal lesions	One day after Catheter ablation	It will be assessed by means of Esophagoscopy

Secondary Outcome Measures

Name	Time	Method
Size of ablation-related esophageal thermal lesions	One day after Catheter ablation	It will be assessed by means of Esophagoscopy
Severity of ablation-related esophageal thermal lesions	One day after Catheter ablation	It will be assessed by means of Esophagoscopy

Trial Locations

Locations (2)

Arash Arya; 🇩🇪 Leipzig, Saxony, Germany

Department of Electrophysiology, Leipzig Heart Center at University of Leipzig; 🇩🇪 Leipzig, Saxony, Germany