Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06023888
• Other study ID #: 2022-12-009C
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: August 2023
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: CHIN-YU LIN, DR
• Phone: +886983215656
• Email: clouaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Mapping strategy
The ablation strategy was based on the mapping results of periodicity.
• Mapping strategy
PVI+ non-PV trigger

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of atrial arrhythmia	atrial arrhythmia in 24-hour monitoring	up to 6 month
Primary	Recurrence of atrial arrhythmia	atrial arrhythmia in 7-day ECG monitoring	up to 1 year