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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• persistent atrial fibrillation

• refractory or intolerant to medication

Locations
Other Locations
Taiwan
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
CHIN-YU LIN, DR
clouaa@gmail.com
+886983215656
Time Frame
Start Date: 2023-06-09
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 80
Treatments
Experimental: Periodicity-based
Other: Control
Standard ablation strategy as usual
Related Therapeutic Areas
Sponsors
Leads: Taipei Veterans General Hospital, Taiwan

This content was sourced from clinicaltrials.gov