Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation

NCT06023888 | Recruiting

• 1 other identifier: 2022-12-009C
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

persistent atrial fibrillation; ablation; driver

Outcome Measures

Primary Outcomes (2)

• Recurrence of atrial arrhythmia

  atrial arrhythmia in 24-hour monitoring

  up to 6 month

• Recurrence of atrial arrhythmia

  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.

  up to 1 year

Study Arms (2)

Periodicity-based

EXPERIMENTAL

Other: Mapping strategy

Control

OTHER

Standard ablation strategy as usual

Other: Mapping strategy

Interventions

Mapping strategy OTHER

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

Periodicity-based

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• persistent atrial fibrillation
• refractory or intolerant to medication

You may not qualify if:

• Previous AF ablation
• LA thrombus
• Previous MAZE procedure
• Poor renal function
• Can't follow-up for one year

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

CHIN-YU LIN, DR

CONTACT

+886983215656; clouaa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 5, 2023
• Study Start: June 9, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

TW (1)