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

NCT04394923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-01-19

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Arrhythmia

Interventions

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.

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

Sponsors & Collaborators

  • Centro Medico Teknon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-22
Primary Completion
2021-03-15
Completion
2022-01-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04394923 on ClinicalTrials.gov