deltatrials
Completed NA INTERVENTIONAL NCT00650728

Esophagus Imaging for Radiofrequency Ablation of Atrial Fibrillation

Esophagus Imaging for Radiofrequency Ablation of Atrial Fibrillation: Comparison of Two Methods

Sponsor: Luzerner Kantonsspital

Updated 7 times since 2017 Last updated: Jun 22, 2011 Started: Mar 31, 2008 Primary completion: May 31, 2009 Completion: May 31, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Atrial Fibrillation, this trial is completed. The trial is conducted by Luzerner Kantonsspital and has accumulated 7 data snapshots since 2008. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Study Description(click to expand)

Percutaneous catheter ablation with circumferential pulmonary vein isolation using radiofrequency energy has become an important therapeutic option to treat atrial fibrillation over the last years. Importing images from pre-acquired 3-D CT or MRI scans into the 3-D mapping system with superimposition of the electro-anatomical map is increasingly used. Despite these advances, the interventional electrophysiologist must be aware of potential complications that are associated with this procedure. As the left atrium is in close vicinity to the esophagus, radiofrequency ablation in the left atrium may damage the esophagus and create esophageal perforations and esophageal left atrial fistula. To prevent this lethal complication integration of an esophagus tag into the electroanatomic left atrium map visualizing the anatomic relationship has been studied und reported. Another possibility of visualization of the esophagus is to perform the CT after placing a conventional radio-opaque gastric tube, which provides information about the course of the esophagus in relation to the LA and may be scanned by CT . It has been shown that under normal conditions, if no barium is administered, there is little change in the anatomical relationship between the posterior left atrium and the esophagus during the entire cardiac cycle. However it is not clear...

Percutaneous catheter ablation with circumferential pulmonary vein isolation using radiofrequency energy has become an important therapeutic option to treat atrial fibrillation over the last years. Importing images from pre-acquired 3-D CT or MRI scans into the 3-D mapping system with superimposition of the electro-anatomical map is increasingly used. Despite these advances, the interventional electrophysiologist must be aware of potential complications that are associated with this procedure. As the left atrium is in close vicinity to the esophagus, radiofrequency ablation in the left atrium may damage the esophagus and create esophageal perforations and esophageal left atrial fistula. To prevent this lethal complication integration of an esophagus tag into the electroanatomic left atrium map visualizing the anatomic relationship has been studied und reported. Another possibility of visualization of the esophagus is to perform the CT after placing a conventional radio-opaque gastric tube, which provides information about the course of the esophagus in relation to the LA and may be scanned by CT . It has been shown that under normal conditions, if no barium is administered, there is little change in the anatomical relationship between the posterior left atrium and the esophagus during the entire cardiac cycle. However it is not clear whether the position of the esophagus in relation to the left atrium is changing over days.

The aim of the present study is to evaluate whether visualization of the esophagus by placing a conventional gastric tube before performing the CT scan and visualization and integration of the esophagus into the 3-D electro-anatomical map the day before ablation is accurate compared with integration of an esophagus tag into the electroanatomic left atrium map visualizing the anatomic relationship during the radiofrequency ablation.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2025 — Present [monthly]

    Completed NA

  3. Sep 2024 — Sep 2025 [monthly]

    Completed NA

  4. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  5. Jan 2021 — Jul 2024 [monthly]

    Completed NA

Show 2 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed NA

  2. Jan 2017 — Jun 2018 [monthly]

    Completed NA

    First recorded

Mar 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Luzerner Kantonsspital
Data source: Luzerner Kantonsspital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations