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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

263 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-09-01

Brief Summary

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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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Detailed Description

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Conditions

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Esophagus Injury Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No