Teknon Medical Center
Barcelona, 08017, Spain
NCT Number: NCT04394923
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Barcelona, 08017, Spain
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:
Interventions
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.
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.
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Blinded to the esophageal position based on the type of AF, closer to the ostium for paroxysmal AF and wider for persistent AF
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
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.
Centro Medico Teknon
Other
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
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