Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation

NCT ID: NCT06023888

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-09

Study Completion Date

2026-06-30

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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Periodicity-based

Group Type EXPERIMENTAL

Mapping strategy

Intervention Type OTHER

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

Control

Standard ablation strategy as usual

Group Type OTHER

Mapping strategy

Intervention Type OTHER

PVI+ non-PV trigger

Interventions

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Mapping strategy

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

Intervention Type OTHER

Mapping strategy

PVI+ non-PV trigger

Intervention Type OTHER

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Chin-Yu Lin

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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CHIN-YU LIN, DR

Role: CONTACT

+886983215656

Facility Contacts

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CHIN-YU LIN

Role: primary

+886983215656

Other Identifiers

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2022-12-009C

Identifier Type: -

Identifier Source: org_study_id

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