Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Atrial fibrillation and, according to current guidelines, indication for radiofrequency ablation guided by electro-anatomical mapping with high-density mapping catheter and radiofrequency ablation by contact force ablation catheter.

• Able to sign the consent form.

Locations
Other Locations
Italy
SOD di Cardiologia e Aritmologia
RECRUITING
Ancona
Contact Information
Primary
Antonio Dello Russo, MD
antonio.dellorusso@ospedaliriuniti.marche.it
+39 ‭0715965798‬
Backup
Franco Noventa, MD
franco.noventa@quovadis-ass.it
+39 049715373
Time Frame
Start Date: 2024-01-08
Estimated Completion Date: 2025-10
Participants
Target number of participants: 51
Treatments
Experimental: Unique Arm
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
Sponsors
Leads: Quovadis Associazione
Collaborators: Abbott

This content was sourced from clinicaltrials.gov