Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657170
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Hidden Slow Conduction Ablation for Recurrent Atrial Fibrillation Unmasking the Arrhythmogenic Substrate Unmask-AF
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hidden Slow Conduction Ablation for Recurrent Atrial Fibrillation Unmasking the Arrhythmogenic Substrate
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Over recent years pulmonary vein isolation PVI procedures have demonstrated progressively enhanced efficacy and safety resulting in a substantial increase in the number of atrial fibrillation ablations not only as a first-line treatment but also for repeat procedures However there is still a notable lack of randomized evidence in this area which limits guidance and decision-making in clinical practice Recently the investigators found that employing short-coupled atrial extrastimuli revealed highly fragmented or double atrial evoked electrograms EGMs in AF patients termed as hidden slow conduction HSC Identifying HSC sites may provide insight into the early identification of the arrhythmogenic substrate offering a potential target for ablation This multi-center prospective randomized controlled trial will include two arms one investigational PV reconnection HSC and one control PV reconnection All the subjects will be followed for 12 months after the ablation procedure
The aim of our study is to investigate the impact of ablating HSC sites on arrhythmia recurrence in repeat ablation procedures The hypothesis is that the additional ablation of HSC zones may improve the freedom from atrial arrhythmia recurrence after repeat ablation procedure
The aim of our study is to investigate the impact of ablating HSC sites on arrhythmia recurrence in repeat ablation procedures The hypothesis is that the additional ablation of HSC zones may improve the freedom from atrial arrhythmia recurrence after repeat ablation procedure
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?:
None