Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation
NCT ID: NCT06023888
Last Updated: 2024-10-17
Study Results
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Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-06-09
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Periodicity-based
Mapping strategy
The ablation strategy was based on the mapping results of periodicity.
Control
Standard ablation strategy as usual
Mapping strategy
PVI+ non-PV trigger
Interventions
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Mapping strategy
The ablation strategy was based on the mapping results of periodicity.
Mapping strategy
PVI+ non-PV trigger
Eligibility Criteria
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Inclusion Criteria
* refractory or intolerant to medication
Exclusion Criteria
* LA thrombus
* Previous MAZE procedure
* Poor renal function
* Can't follow-up for one year
20 Years
80 Years
ALL
No
Sponsors
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Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Chin-Yu Lin
Doctor
Locations
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Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-12-009C
Identifier Type: -
Identifier Source: org_study_id
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