CompletedNCT05709756VISUAL-AFUpdated Oct 2, 2023

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

An observational study in Esophagus Injury and Atrial Fibrillation, sponsored by Helios Health Institute GmbH. Completed at 2 sites in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-02.

Sponsored by Helios Health Institute GmbH · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 263
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Esophagus Injury
Atrial Fibrillation

Browse trials for

Atrial Fibrillation 3,870

Keywords

Atrial Fibrillation
Esophagus Injury
Pulmonary vein isolation
Esophagoscopy

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 263 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Helios Health Institute GmbH is the lead sponsor of 17 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
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

Inclusion criteria

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

Exclusion criteria

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

Observational model: Case-only
Time perspective: Prospective
Enrollment: 263 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

2 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05709756
Lead sponsor: Helios Health Institute GmbH
Responsible party: Sponsor
First posted: Feb 2, 2023
Start date: Mar 1, 2021
Primary completion: Aug 1, 2023
Completion: Sep 1, 2023
Last update: Oct 2, 2023

Study contacts

Gerhard Hindricks, MD

study chair · Leipzig Heart Center at University of Leipzig

Arash Arya, MD

study director · Leipzig Heart Center at University of Leipzig

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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