Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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STUDY DESIGN A prospective study. OBJECTIVE A single center clinical trial on the analysis of intracardiac atrial electrogram waveform periodicity for catheter ablation of persistent atrial fibrillation with OCTARAY™ Mapping Catheter, as prospective randomized controlled study. HYPOTHESIS: The critical atrial substrates in maintaining persistent atrial fibrillation could be identified by non-linear electrogram morphology analysis in a point-by-point electroanatomic mapping. Based on the previous study, atrial substrate with high-similarity electrogram regions correlated with procedural AF termination and better long-term AF-free (1). Therefore, we proposed that the degree of waveform similarity plus the beat-to-beat sequential morphology (2) (duration of how many similar waveforms can maintain in sequence) would be even better to characterize the atrial substrate and could be potentially critical atrial substrate in prediction of sources of AF. As additional substrate mapping provided benefits compared to PVI alone in patients with persistent AF, we hypothesize that waveform periodicity adjuvant to electrogram similarity and phase mapping could be used to guide radiofrequency ablation in real time. The used of the OCTARAY™ Mapping Catheter could collected more AF electrogram and facilitate the mapping resolution and driver identification.

Official Title
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A Prospective Randomized Controlled Study on the Waveform Periodicity Analysis of Complex Fractionated Electrograms With OctaRay in Patients With Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Mapping strategy
* Other: Mapping strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: persistent atrial fibrillation refractory or intolerant to medication Exclusion Criteria: Previous AF ablation LA thrombus Previous MAZE procedure Poor renal function Can't follow-up for one year

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study was designed to determine the efficacy of substrate ablation using waveform periodicity analysis, similarity analysis with OCTARAY™ Mapping Catheter could collected more AF electrogram and facilitate the mapping resolution and driver identification., plus phase mapping in persistent AF patients who required substrate modification.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periodicity-based<br> | Other: Mapping strategy<br>* The ablation strategy was based on the mapping results of periodicity.<br>|
| Other: Control<br>Standard ablation strategy as usual | Other: Mapping strategy<br>* PVI+ non-PV trigger<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial arrhythmia | atrial arrhythmia in 24-hour monitoring | up to 6 month | 
| Recurrence of atrial arrhythmia | atrial arrhythmia in 7-day ECG monitoring | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ablation, persistent atrial fibrillation, driver