NCT05758805|Unknown
Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF (ESO-SAFE-HP-RF)
ESO-SAFE-HP-RF
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ESO-SAFE-HP-RF
Sponsor study identifier
interventional
51
1 country
1
Study Start
January 8, 2024
Actual (reported)Primary Completion
July 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This pilot, prospective, interventional, monocentric, independent, and no-profit clinical trial aims to investigate and evaluate the proportion, acute and chronic characteristics, and outcomes of esophageal thermal injury (ETI) in AF ablation using a high-power, short-duration (HP-SD) setting with contact force (CF) sensing tip ablation catheter in standard clinical practice. The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 21, 2023
Actual (reported)March 7, 2023
Actual (reported)January 8, 2024
Actual (reported)July 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Proportion of the acute esophageal thermal injury (ETI)
Evaluate the acute proportion of the esophageal thermal injury (ETI)
1-3 days after AF ablation procedure
Factors influencing RF procedure on ETI development
1-3 days after AF ablation procedure
Esophageal temperature by an esophageal continuous monitoring device
during AF ablation procedure
patients with atrial fibrillation and indication for radiofrequency ablation guided by electro-anatomical mapping with high-density mapping catheter and radiofrequency ablation by contact force ablation catheter, according to current guidelines
mini-invasive esophagoscopy assessment of esophageal thermal injury (ETI) after an AF ablation session in an HP-SD setting, and with a tip CF sensing ablation catheter
AF ablation session in an HP-SD setting and with a tip CF sensing ablation catheter
SOD di Cardiologia e Aritmologia
Ancona, 60126, Italy
Antonio Dello Russo, MD
Cardiology and Arrhythmology Dept., Azienda Ospedaliero Universitaria delle Marche, Ancona (Italy)
First Submitted
February 21, 2023
First Posted
March 7, 2023
Study Start
January 8, 2024
Actual (reported)Primary Completion
July 2025
ETI monitoring
12 months after AF ablation procedure
AF ablation procedure times
1 day
AF recurrences
12 months after AF ablation procedure
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 9, 2024
Record last verified: 2024-05
no IPD share planned
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Source: ClinicalTrials.gov.
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