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OpenTrials
Completed

NCT Number: NCT04394923

Relationship Between the Posterior Atrial Wall and the Esophagus: Esophageal Position and Temperature MEasurement During Atrial Fibrillation Ablation.

A multimodal strategy integrating esophageal visualization with the multidetector computed tomography (MDCT) and simultaneous temperature monitoring has never been put into practice. We have developed an isodistance map (esophageal print) to depict the atrio-esophageal relationship and to analyze the esophageal position peri procedurally. The present randomized study intends to analyze the usefulness of the esophageal print in predicting local thermal heating of the esophagus.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Teknon Medical Center

Barcelona, 08017, Spain

About this study

Primary objective: to validate the usefulness of the esophageal print in avoiding temperature rises caused by radiofrequency (RF) application at the left atrial (LA) posterior wall during atrial fibrillation ablation

Secondary objectives:

  • to establish if there is a linear relationship between intraesophageal temperature rise and atrio-esophageal distance as calculated by the MDCT-derived esophageal print.
  • to analyze the need for ablation line modification.
  • to analyze the need for energy (power settings, ablation index, ablation time, etc.) modification.
  • to develop a new multimodal approach to esophageal monitoring during AF/AT ablation.

Interventions

  • Pre-procedural scan and Esophageal Isodistance Print

The methods for the acquisition of the cardiac MDCT and the image processing have been described in Part 1. During the segmentation process, the epicardial layer of the posterior atrial wall and the esophageal wall have been defined. The distance between these two structures is computed at each epicardial point, allowing to create an esophageal print on top of the epicardial layer. The isodistance color map uses a color scale to depict a range of distance; red being the closest (< 1 mm) and purple being the most distant (> 4 mm). Yellow, green and blue will be considered the intermediate values.

  • Luminal esophageal temperature (LET) monitoring

A multi-thermocouple temperature probe (SensiTherm, St. Jude Medical, Inc., St. Paul, MN, USA) will be advanced via transnasal or transoral access into the esophagus once the patient is under general anesthesia. When the esophageal print is close to the ablation line, the temperature probe position will be adjusted under fluoroscopic guidance before application at each pair of pulmonary veins to ensure that it overlaps the ablation line. All esophageal temperature rises above 39 °C will be documented and RF application will be stopped.

  • Pulmonary vein ablation lines regarding Esophageal Isodistance Print

Before randomization, an investigator blinded to the esophageal position will draw the PVI ablation line around both pairs of veins based on the type of AF (closer to the ostium for paroxysmal AF and wider for persistent AF).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years.
  • Indication for any atrial fibrillation or left atrial flutter ablation procedure.
  • Documented episodes of atrial arrhythmia (AF/AT/AFL)
  • Signed informed consent.

Exclusion criteria

  • Age < 18 years.
  • Pregnancy.
  • Impossibility to perform CT Scan.
  • Impossibility to perform transesophageal echocardiography or to insert esophageal temperature monitoring probe.
  • Concomitant investigation treatments.
  • Medical, geographical and social factors that make study participation impractical
  • Inability to give written informed consent.
  • Patient's refusal to participate in the study.

Treatment and study plan

Modification of the pulmonary vein ablation line

Procedure

The ablation line previously drawn will be modified regarding the esophageal print position in order to avoid RF application within the red layer of the esophageal print.

Regular PVI ablation

Procedure

Blinded to the esophageal position based on the type of AF, closer to the ostium for paroxysmal AF and wider for persistent AF

Primary outcomes

  1. Proportion of participants presenting a temperature rise as measured with a luminal esophageal temperature probe during radiofrequency delivery. The temperature is measured in Celsius degrees.

    Time frame: 1 day

    Number of intraesophageal temperature rises above 39°C or absolute temperature raises of 2°C degrees. The chosen probe is St Jude

Secondary outcomes

  1. Proportion of patients needing ablation power or ablation time modification owing to esophageal presence in the immediate posterior wall .

    Time frame: 1 day

    Modification of the ablation parameters.Power is measured in Watts during radiofrequency application. Ablation time is measured in seconds of radiofrequency application. Both measures are provided by the electroanatomical navigation system.

Sponsors and collaborators

Lead sponsor

Centro Medico Teknon

Other

Registry information

Official study title

Impact of Pulmonary Vein Isolation (PVI) Line Modification Based on the Multidetector Computed Tomography (MDCT)-Derived Fingerprinted Esophageal Distance to the Posterior Wall of the Left Atrium, on the Esophageal Temperature Raise Measured With an Intraluminal Esophageal Temperature Monitoring Lead. A Randomized Controlled Study.

Acronym: AWESOME-AF

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 20, 2020
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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