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Clinical Trials/NCT06023888
NCT06023888RecruitingNot Applicable

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

Taipei Veterans General Hospital, Taiwan1 site in 1 country80 target enrollmentStarted: June 9, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
80
Locations
1
Primary Endpoint
Recurrence of atrial arrhythmia

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Periodicity-based

Experimental

Intervention: Mapping strategy (Other)

Control

Other

Standard ablation strategy as usual

Intervention: Mapping strategy (Other)

Outcomes

Primary Outcomes

Recurrence of atrial arrhythmia

Time Frame: 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.

Recurrence of atrial arrhythmia

Time Frame: up to 6 month

atrial arrhythmia in 24-hour monitoring

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Chin-Yu Lin

Doctor

Taipei Veterans General Hospital, Taiwan

Study Sites (1)

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