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

Atrial Fibrillation Clinical Trial

— VISUAL-AF  

Official title:

Prevalence and Predictors of Esophageal Thermal Lesions in High-Power-Short-Duration Ablation of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05709756
• Other study ID #: 549/20-ek
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2023
• Source: Helios Health Institute GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Esophagus Injury

Locations

Country	Name	City	State
Germany	Arash Arya	Leipzig	Saxony
Germany	Department of Electrophysiology, Leipzig Heart Center at University of Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Helios Health Institute GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of ablation-related esophageal thermal lesions	It will be assessed by means of Esophagoscopy	One day after Catheter ablation
Secondary	Size of ablation-related esophageal thermal lesions	It will be assessed by means of Esophagoscopy	One day after Catheter ablation
Secondary	Severity of ablation-related esophageal thermal lesions	It will be assessed by means of Esophagoscopy	One day after Catheter ablation