Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632925
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Utility of Analyzing Atrial Signal Electrograms in Patients with Atrial Fibrillation Using Next-Generation Ensite X Software a Prospective Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Utility of Analyzing Atrial Signal Electrograms in Patients with Atrial Fibrillation Using Next-Generation Ensite X Software a Prospective Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A single-center clinical trial on the analysis of intracardiac atrial electrogram mapping before and after ablation with the HD Grid Mapping Catheter and Ensite X Software as a prospective study
Detailed Description:
This study was designed to determine the efficacy of substrate ablation using HD Grid Mapping Catheter could collected more AF electrogram and facilitate the mapping resolution and driver identification in AF patients who required substrate modification This study is a prospective single-center in which patients with AF who will receive catheter ablation
The priority of substrate modification would be determined by the mapping with the HD Grid mapping catheter The end-point of ablation is non-inducible of AF or AFL The procedure time fluoroscopic time procedural termination rate and recurrence of atrial arrhythmia would be collected If the flutter or the non-PV triggers were inducible isthmus ablation and the non-PV trigger ablation will be performed accordingly
The priority of substrate modification would be determined by the mapping with the HD Grid mapping catheter The end-point of ablation is non-inducible of AF or AFL The procedure time fluoroscopic time procedural termination rate and recurrence of atrial arrhythmia would be collected If the flutter or the non-PV triggers were inducible isthmus ablation and the non-PV trigger ablation will be performed accordingly
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None