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

Sponsor

Leipzig Heart Institute GmbH (Other)

Overall Status

Recruiting

CT.gov ID

NCT05709756

Collaborator

(none)

263

Enrollment

Locations

Anticipated Duration (Months)

131.5

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

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:

The size of the esophageal thermal lesions.
The severity of esophageal thermal lesions.

Condition or Disease	Intervention/Treatment	Phase
Esophagus Injury Atrial Fibrillation

Study Design

Study Type:

Observational

Anticipated Enrollment :

263 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Outcome Measures

Primary Outcome Measures

Prevalence of ablation-related esophageal thermal lesions [One day after Catheter ablation]
It will be assessed by means of Esophagoscopy

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arash Arya	Leipzig	Saxony	Germany	04289
2	Department of Electrophysiology, Leipzig Heart Center at University of Leipzig	Leipzig	Saxony	Germany	04289

Sponsors and Collaborators

Leipzig Heart Institute GmbH

Investigators

Study Chair: Gerhard Hindricks, MD, Leipzig Heart Center at University of Leipzig
Study Director: Arash Arya, MD, Leipzig Heart Center at University of Leipzig