Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Other: Mapping strategy

• Registration Number: NCT06023888
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-09
• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periodicity-based	Mapping strategy	-
Control	Mapping strategy	Standard ablation strategy as usual

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial arrhythmia	up to 1 year	atrial arrhythmia in 7-day ECG monitoring(RootiRx®); The RootiRx® multi-sensor patch-type system is a water-resistant compact ECG patch of 62 × 22 × 9mm size and 14g of weight. It is applied on the patient left chest similar to lead II location and it is fixed on a disposable self-adhesive patch then connected to the skin with two electrodes. RootiRx Syste can make continuous ECG monitoring up to seven days at a sampling frequency of 250Hz with 24-bit high resolution. Proprietary algorithms are used to analyze recorded data.

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan