CompletedNot Applicable

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

Germany263 participantsStarted 2021-03-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevalence of ablation-related esophageal thermal lesions

Timeframe: One day after Catheter ablation

Trial details

NCT IDNCT05709756

SponsorHelios Health Institute GmbH

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-08-01

View on ClinicalTrials.gov More Esophagus Injury trials