Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Recruiting

CT.gov ID

NCT06023888

Collaborator

(none)

Enrollment

Location

Arms

36.7

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Other: Mapping strategy Other: Mapping strategy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 9, 2023

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Periodicity-based

Other: Mapping strategy

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

Other: Control

Standard ablation strategy as usual

Other: Mapping strategy

PVI+ non-PV trigger

Outcome Measures

Primary Outcome Measures

Recurrence of atrial arrhythmia [up to 6 month]
atrial arrhythmia in 24-hour monitoring
Recurrence of atrial arrhythmia [up to 1 year]
atrial arrhythmia in 7-day ECG monitoring

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei		Taiwan	112

Sponsors and Collaborators

Taipei Veterans General Hospital, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chin-Yu Lin, Doctor, Taipei Veterans General Hospital, Taiwan

ClinicalTrials.gov Identifier:

NCT06023888

Other Study ID Numbers:

2022-12-009C

First Posted:

Sep 5, 2023

Last Update Posted:

Sep 5, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chin-Yu Lin, Doctor, Taipei Veterans General Hospital, Taiwan

persistent atrial fibrillation

ablation

driver

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Sep 5, 2023