Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05426603
Status:
RECRUITING
Last Update Posted:
2022-06-22
First Post:
2022-05-15
Brief Title:
Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation
Sponsor:
Buddhist Tzu Chi General Hospital
Organization:
Buddhist Tzu Chi General Hospital
Study Overview
Official Title:
A Randomized Controlled Study on the Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2022-04
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:
None
Brief Summary:
Atrial fibrillation AF has been the most frequently occurring sustained arrhythmia which causes significant morbidity and mortality AF may not always be a totally random process It can be maintained by stable and rapid reentrant circuits resulting in fibrillary conduction throughout the atria During mapping of AF difficulty is frequently encountered during the identification of culprit sites and an analysis of the wave propagation particularly when the electrogram signals demonstrate wide temporal and spatial disparities Catheter ablation targeting regions with fractionated potentials or high frequencies during AF has been previously proposed as a treatment strategy However the benefit of adjunctive CFAE complex fractionated atrial electrogram ablation or linear ablation after successful PVI pulmonary vein isolation was controversial based on the recent data from the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II STAR AF II trial Therefore the optimal ablation strategy for persistent AF remains undetermined and an alternative approach has to be explored
Detailed Description:
In this prospective trial investigators will investigate the long-term efficacy of catheter ablation of non-paroxysmal AF based on selective atrial substrate modification eg wavefrom periodicity analysis similarity plus phase mapping 1 The control group would be PV isolation alone The primary end point is long-term recurrence of atrial arrhythmias The secondary end points composite procedural termination the safety of the procedure recurrence of multiple procedures and change of atrial and ventricular function after catheter ablation
The inclusion criteria exclusion criteria stepwise catheter ablation procedures PVI and then substrate modification and the follow-up procedure are the same as current treatment approaches in patients with non-paroxysmal AF
The inclusion criteria exclusion criteria stepwise catheter ablation procedures PVI and then substrate modification and the follow-up procedure are the same as current treatment approaches in patients with non-paroxysmal AF
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