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NCT04394923: AWESOME-AF

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

Completed NA Last updated 19 January 2022
What this trial tests

NA trial testing Modification of the pulmonary vein ablation line in Atrial Arrhythmia in 64 participants. Completed in 15 January 2022.

Timeline
22 June 2020
Primary endpoint
15 March 2021
15 January 2022

Quick facts

Lead sponsorCentro Medico Teknon
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment64
Start date22 June 2020
Primary completion15 March 2021
Estimated completion15 January 2022
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Centro Medico Teknon — full company profile →

Who can join

18 and older, any sex, with Atrial Arrhythmia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Relationship between the posterior atrial wall and the esophagus: esophageal position and temperature measurement during atrial fibrillation ablation (AWESOME-AF). A randomized controlled trial.
    Teres C, Soto-Iglesias D, Penela D, Falasconi G, et al · · 2022 · cited 15× · PMID 35861901 · DOI 10.1007/s10840-022-01302-0
  2. Relationship between the posterior atrial wall and the esophagus: Esophageal position during atrial fibrillation ablation.
    Teres C, Soto-Iglesias D, Penela D, Jáuregui B, et al · · 2022 · cited 1× · PMID 35734293 · DOI 10.1016/j.hroo.2022.02.007

Verify or expand the search:

Other recruiting trials for Atrial Arrhythmia

Currently open trials in the same condition.

Other Centro Medico Teknon trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04394923.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing