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Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF (ESO-SAFE-HP-RF)

NCT05758805 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-05-09

No results posted yet for this study

Summary

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:

* Evaluate the acute proportion of the ETI assessed by the mini-invasive esophagoscopy pre and post-procedure. In addition, clinical evaluations at 3, 6, and 12 months from the procedure are foreseen.
* Evaluate the contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development.
* Describe the relationship between the esophageal temperature (continuous monitoring) and ETI development.

Conditions

Interventions

DEVICE

mini-invasive esophagoscopy

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

DEVICE

HP-SD AF ablation by a CF sensing catheter

AF ablation session in an HP-SD setting and with a tip CF sensing ablation catheter

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Quovadis Associazione

    lead OTHER

Principal Investigators

  • Antonio Dello Russo, MD · Cardiology and Arrhythmology Dept., Azienda Ospedaliero Universitaria delle Marche, Ancona (Italy)

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2025-07-31
Completion
2025-10-31

Countries

  • Italy

Study Locations

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Diseases
Companies

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 NCT05758805 on ClinicalTrials.gov