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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Esophagus Injury

• Study Type: Observational
• Enrollment (Actual): 263

Contacts and Locations

• Study Contact: Name: Arash Arya, MD; Phone Number: +49341865252009; Email: arash.arya@helios-gesundheit.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Arash Arya
    • Leipzig, Saxony, Germany, 04289
      • Department of Electrophysiology, Leipzig Heart Center at University of Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with documented atrial fibrillation who were referred to our clinic for pulomary vein isolation

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of ablation-related esophageal thermal lesions	It will be assessed by means of Esophagoscopy	One day after Catheter ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of ablation-related esophageal thermal lesions	It will be assessed by means of Esophagoscopy	One day after Catheter ablation
Severity of ablation-related esophageal thermal lesions	It will be assessed by means of Esophagoscopy	One day after Catheter ablation

Collaborators and Investigators

• Sponsor: Helios Health 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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Pulmonary vein isolation; Esophagoscopy; Esophagus Injury
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 549/20-ek

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No