Esophagus InjuryVISUAL-AFNCT05709756
Prevalence and Predictors of Esophageal Thermal Lesions in High-power-Short-duration Ablation of Atrial Fibrillation
An observational study of Esophagus Injury and Atrial Fibrillation, run by Helios Health Institute GmbH at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophagus Injury, Atrial Fibrillation
- How many people
- 263 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Mar 2021to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with documented atrial fibrillation who were referred to our clinic for pulomary vein isolation
Who may be able to join
- Atrial fibrillation documented in the 12-lead ECG
- Indication for catheter ablation in accordance with currentn ESC guidelines
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Arash Arya
Leipzig, Saxony, 04289
Department of Electrophysiology, Leipzig Heart Center at University of Leipzig
Leipzig, Saxony, 04289
About this study
Official title: Prevalence and Predictors of Esophageal Thermal Lesions in High-Power-Short-Duration Ablation of Atrial Fibrillation
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:
- The size of the esophageal thermal lesions.
- The severity of esophageal thermal lesions.
- Conditions
- Esophagus Injury, Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Esophagus Injury, Pulmonary vein isolation, Esophagoscopy
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ablation-related esophageal thermal lesions
It will be assessed by means of Esophagoscopy
Measured: One day after Catheter ablation
Secondary outcomes (2)
Size of ablation-related esophageal thermal lesions
It will be assessed by means of Esophagoscopy
Measured: One day after Catheter ablation
Severity of ablation-related esophageal thermal lesions
It will be assessed by means of Esophagoscopy
Measured: One day after Catheter ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Mar 2021
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophagus InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Health Institute GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerhard Hindricks, MD, Study chair, Leipzig Heart Center at University of LeipzigArash Arya, MD, Study director, Leipzig Heart Center at University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709756
- Sponsor's protocol ID
- 549/20-ek
- Acronym
- VISUAL-AF
- Status last verified
- Jan 2023
- First submitted
- 24 Jan 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38646922
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Predictors of Esophageal Thermal Lesions in High-Power-Short-Duration Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05709756
- Acronym / sponsor ID
- VISUAL-AF / 549/20-ek
- Conditions
- Esophagus Injury, Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Esophagus Injury, Pulmonary vein isolation, Esophagoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Helios Health Institute GmbHUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The size of the esophageal thermal lesions.
- The severity of esophageal thermal lesions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with documented atrial fibrillation who were referred to our clinic for pulomary vein isolation
Key inclusion criteria (2 listed)
- Atrial fibrillation documented in the 12-lead ECG
- Indication for catheter ablation in accordance with currentn ESC guidelines
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of ablation-related esophageal thermal lesions
Time frame: One day after Catheter ablation
It will be assessed by means of Esophagoscopy
2 secondary outcomes
Size of ablation-related esophageal thermal lesions
Time frame: One day after Catheter ablation
Severity of ablation-related esophageal thermal lesions
Time frame: One day after Catheter ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Derived from this study: PubMed 38646922Wolff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Hindricks, MD study chair
Leipzig Heart Center at University of Leipzig
Arash Arya, MD study director
Leipzig Heart Center at University of Leipzig
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagus Injury and Atrial Fibrillation, run by Helios Health Institute GmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ablation-related esophageal thermal lesions (time frame: One day after Catheter ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05709756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.