Relationship Between the Posterior Atrial Wall and the Esophagus: Esophageal Position and Temperature MEasurement During Atrial Fibrillation Ablation. (AWESOME-AF)

January 17, 2022 updated by: Antonio Berruezo, MD, PhD, Centro Medico Teknon

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

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

Interventions

  1. 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.

  2. 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.

  3. 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).

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08017
        • Teknon Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group or "PRINT" group
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, which is the zone where the atrioesophageal distance is shorter. The maximal distance and the area between the original line and the modified line will be noted. In cases when ablation through the red layer is unavoidable, the delivered energy can be lowered to an ablation index (AI) of 300 regardless of the local wall thickness. If the temperature rises above 39℃, ablation will be immediately stopped, and energy will be reduced.
Procedure: Modification of the pulmonary vein ablation line
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.
Other: Control group
The ablation line will not be modified from the original one drawn before randomization and RF applications will follow the regular path. If the temperature rises above 39℃, ablation will be immediately stopped, and energy will be reduced.
Procedure: Regular PVI ablation
Blinded to the esophageal position based on the type of AF, closer to the ostium for paroxysmal AF and wider for persistent AF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Medico Teknon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2020

Primary Completion (Actual)

March 15, 2021

Study Completion (Actual)

January 15, 2022

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 17, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AWESOME-AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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