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

NCT05709756 | Completed

• 1 other identifier: 549/20-ek
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 2

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

Conditions

Esophagus Injury; Atrial Fibrillation

Keywords

Atrial Fibrillation; Esophagus Injury; Pulmonary vein isolation; Esophagoscopy

Outcome Measures

Primary Outcomes (1)

• Prevalence of ablation-related esophageal thermal lesions

  It will be assessed by means of Esophagoscopy

  One day after Catheter ablation

Secondary Outcomes (2)

• Size of ablation-related esophageal thermal lesions

  One day after Catheter ablation

• Severity of ablation-related esophageal thermal lesions

  One day after Catheter ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with documented atrial fibrillation who were referred to our clinic for pulomary vein isolation

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helios Health Institute GmbH: lead

Study Sites (2)

Arash Arya

Leipzig, Saxony, 04289, Germany

Location

Department of Electrophysiology, Leipzig Heart Center at University of Leipzig

Leipzig, Saxony, 04289, Germany

Location

Related Publications (1)

• Wolff C, Langenhan K, Wolff M, Efimova E, Zachaus M, Darma A, Dinov B, Seewoster T, Nedios S, Bertagnolli L, Wolff J, Paetsch I, Jahnke C, Bollmann A, Hindricks G, Bode K, Halm U, Arya A. Incidence and predictors of thermal oesophageal and vagus nerve injuries in Ablation Index-guided high-power-short-duration ablation of atrial fibrillation: a prospective study. Europace. 2024 May 2;26(5):euae107. doi: 10.1093/europace/euae107.

  PMID: 38646922 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerhard Hindricks, MD

  Leipzig Heart Center at University of Leipzig

  STUDY CHAIR

• Arash Arya, MD

  Leipzig Heart Center at University of Leipzig

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: March 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-01

Locations

DE (2)