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OpenTrials
Completed

NCT Number: NCT05709756

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.

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Key information

Conditions

Esophagus Injury Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arash Arya, Leipzig, Saxony, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of ablation-related esophageal thermal lesions

    Time frame: One day after Catheter ablation

    It will be assessed by means of Esophagoscopy

Secondary outcomes

  1. Size of ablation-related esophageal thermal lesions

    Time frame: One day after Catheter ablation

    It will be assessed by means of Esophagoscopy

  2. Severity of ablation-related esophageal thermal lesions

    Time frame: One day after Catheter ablation

    It will be assessed by means of Esophagoscopy

Sponsors and collaborators

Lead sponsor

Helios Health Institute GmbH

Other

Registry information

Acronym: VISUAL-AF

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2023
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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