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Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation

T

Taipei Veterans General Hospital

Status

Enrolling

Conditions

Atrial Fibrillation

Treatments

Other: Mapping strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT06023888
2022-12-009C

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Periodicity-based
Experimental group
Treatment:
Other: Mapping strategy
Other: Mapping strategy
Control
Other group
Description:
Standard ablation strategy as usual
Treatment:
Other: Mapping strategy
Other: Mapping strategy

Trial contacts and locations

1

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Central trial contact

CHIN-YU LIN, DR

Data sourced from clinicaltrials.gov

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