Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT05709756
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2023-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence and Predictors of Esophageal Thermal Lesions in High-power-Short-duration Ablation of Atrial Fibrillation
Sponsor:
Helios Health Institute GmbH
Organization:
Study Overview
Official Title:
Prevalence and Predictors of Esophageal Thermal Lesions in High-Power-Short-Duration Ablation of Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VISUAL-AF
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: