Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05758805
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-02-21
Brief Title:
Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF ESO-SAFE-HP-RF
Sponsor:
Quovadis Associazione
Organization:
Quovadis Associazione
Study Overview
Official Title:
Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESO-SAFE-HP-RF
Brief 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
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
Detailed Description:
This study aims to estimate the proportion of esophageal thermal injury ETI as a result of the AF ablation using a high-power short-duration HP-SD setting with contact force CF sensing tip ablation catheter immediately after and at 3 6 and 12 months from the procedure as well as describe their characteristics
To be more sensitive and specific in detecting the presence of potentially chronic and progressing ETIs in esophageal ulcers and atrium-esophageal fistula a minimally invasive esophagogastroscope will be used before 1-7 days and after 1-3 days the ablation procedure with an internal comparison of the lesions observed In addition various clinical characteristics of the patients and descriptors of the ablation procedure such as contact force impedance RF power RF time esophageal temperature procedure times etc will be collected and related to the presence of ETI
The principal Medical Devices that will be used
1 Cardiac Mapping system Ensite X Abbott Medical
2 Tip CF sensing catheter TactiFlex Abbott Medical
3 High mapping density catheter HD GRIDAdvisor FL Abbott Medical
4 Continuous temperature monitoring devices Esotest MultiEsotherm 7 poles FIAB
5 Video-endoscope EXERA III HDTV dual focus GIF-HQ190 Olympus
To be more sensitive and specific in detecting the presence of potentially chronic and progressing ETIs in esophageal ulcers and atrium-esophageal fistula a minimally invasive esophagogastroscope will be used before 1-7 days and after 1-3 days the ablation procedure with an internal comparison of the lesions observed In addition various clinical characteristics of the patients and descriptors of the ablation procedure such as contact force impedance RF power RF time esophageal temperature procedure times etc will be collected and related to the presence of ETI
The principal Medical Devices that will be used
1 Cardiac Mapping system Ensite X Abbott Medical
2 Tip CF sensing catheter TactiFlex Abbott Medical
3 High mapping density catheter HD GRIDAdvisor FL Abbott Medical
4 Continuous temperature monitoring devices Esotest MultiEsotherm 7 poles FIAB
5 Video-endoscope EXERA III HDTV dual focus GIF-HQ190 Olympus
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None