RecruitingNot ApplicableNCT06023888

Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation

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


Sponsor

Taipei Veterans General Hospital, Taiwan

Enrollment

80 participants

Start Date

Jun 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria2

  • persistent atrial fibrillation
  • refractory or intolerant to medication

Exclusion Criteria5

  • Previous AF ablation
  • LA thrombus
  • Previous MAZE procedure
  • Poor renal function
  • Can't follow-up for one year

Interventions

OTHERMapping strategy

The ablation strategy was based on the mapping results of periodicity.

OTHERMapping strategy

PVI+ non-PV trigger


Locations(1)

Taipei Veterans General Hospital

Taipei, Taiwan

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NCT06023888


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