Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT05758805
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
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 GRID/Advisor FL, Abbott Medical),
4. Continuous temperature monitoring devices (Esotest Multi/Esotherm 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 GRID/Advisor FL, Abbott Medical),
4. Continuous temperature monitoring devices (Esotest Multi/Esotherm 7 poles, FIAB),
5. Video-endoscope EXERA III HDTV dual focus GIF-HQ190 (Olympus).
Study Oversight
Has Oversight DMC:
False
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?: