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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05709756
Acronym
VISUAL-AF
Enrollment
263
Registered
2023-02-02
Start date
2021-03-01
Completion date
2023-09-01
Last updated
2023-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Esophagus Injury

Keywords

Atrial Fibrillation, Esophagus Injury, Pulmonary vein isolation, Esophagoscopy

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: 1. The size of the esophageal thermal lesions. 2. The severity of esophageal thermal lesions.

Interventions

None listed

Sponsors

Helios Health Institute GmbH
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of ablation-related esophageal thermal lesionsOne day after Catheter ablationIt will be assessed by means of Esophagoscopy

Secondary

MeasureTime frameDescription
Size of ablation-related esophageal thermal lesionsOne day after Catheter ablationIt will be assessed by means of Esophagoscopy
Severity of ablation-related esophageal thermal lesionsOne day after Catheter ablationIt will be assessed by means of Esophagoscopy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026