Ignite Creation Date:
2025-12-18 @ 8:28 AM
Ignite Modification Date:
2025-12-23 @ 11:16 PM
Study NCT ID:
NCT03759912
Status:
None
Last Update Posted:
2023-05-31 00:00:00
First Post:
2018-11-25 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultra-High-Resolution Mapping Guided Partial Antral Ablation for AF
Sponsor:
None
Organization:
Study Overview
Official Title:
The Efficacy of Ultra-High-Resolution Mapping Guided Partial Antral Ablation for Atrial Fibrillation
Status:
None
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial stopped prematurely because of enrollment challenges.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAILOR
Brief Summary:
The electrical isolation of the pulmonary veins (PVI) is the cornerstone of current ablation techniques for the treatment of atrial fibrillation (AF) because the PV is the most common trigger of AF. Wide bi-antral circumferential ablation (WACA) is more effective than segmental PV isolation in achieving freedom from total atrial tachyarrhythmia recurrence at long-term follow-up. Therefore, it is widely accepted as initial ablation strategy. However, the WACA technique requires a much larger number of ablation and higher energy to achieve complete isolation because of thick atrial myocardial sleeves with multiple muscle layers present in most of the PV antrum, which is less likely to achieve homogenous transmural lesions in the entire circumference with the currently available ablation technologies. Meanwhile, muscular discontinuities and abrupt changes of the fiber orientation in human PV-Left atrium (LA) junction are previously reported, and electrical PV isolation can usually be achieved without complete circumferential ablation. However, the current electroanatomical mapping (EAM) system has a limitation to understand the complex relationship of PV-LA junction mainly due to relatively low resolution.
The Rhythmia mapping system (BostonScientific, Inc, Cambridge, MA) is a new system provides ultra-high-resolution EAM using a small basket array of 64 electrodes (IntellaMap Orion, Boston Scientific). Owing to better resolution, this new system capable of rapidly and accurately identify critical isthmuses and low-voltage regions of interest and also allows automatic acquisition and accurate annotation of the electrograms, without the need for manual correction.
In this context, we hypothesized that rapid and precise identification of activation pattern of PV-LA junction by Rhythmia system could allow complete, durable electrical isolation of PVs without circumferential antral ablation.
The Rhythmia mapping system (BostonScientific, Inc, Cambridge, MA) is a new system provides ultra-high-resolution EAM using a small basket array of 64 electrodes (IntellaMap Orion, Boston Scientific). Owing to better resolution, this new system capable of rapidly and accurately identify critical isthmuses and low-voltage regions of interest and also allows automatic acquisition and accurate annotation of the electrograms, without the need for manual correction.
In this context, we hypothesized that rapid and precise identification of activation pattern of PV-LA junction by Rhythmia system could allow complete, durable electrical isolation of PVs without circumferential antral ablation.
Detailed Description:
None
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?: