Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Mapping strategy
Mapping strategy
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring persistent atrial fibrillation, ablation, driver
Eligibility Criteria
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
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Periodicity-based
Control
Arm Description
Standard ablation strategy as usual
Outcomes
Primary Outcome Measures
Recurrence of atrial arrhythmia
atrial arrhythmia in 24-hour monitoring
Recurrence of atrial arrhythmia
atrial arrhythmia in 7-day ECG monitoring
Secondary Outcome Measures
Full Information
NCT ID
NCT06023888
First Posted
August 29, 2023
Last Updated
September 4, 2023
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT06023888
Brief Title
Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation
Official Title
A Prospective Randomized Controlled Study on the Waveform Periodicity Analysis of Complex Fractionated Electrograms With OctaRay in Patients With Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
persistent atrial fibrillation, ablation, driver
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Periodicity-based
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Arm Description
Standard ablation strategy as usual
Intervention Type
Other
Intervention Name(s)
Mapping strategy
Intervention Description
The ablation strategy was based on the mapping results of periodicity.
Intervention Type
Other
Intervention Name(s)
Mapping strategy
Intervention Description
PVI+ non-PV trigger
Primary Outcome Measure Information:
Title
Recurrence of atrial arrhythmia
Description
atrial arrhythmia in 24-hour monitoring
Time Frame
up to 6 month
Title
Recurrence of atrial arrhythmia
Description
atrial arrhythmia in 7-day ECG monitoring
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CHIN-YU LIN, DR
Phone
+886983215656
Email
clouaa@gmail.com
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHIN-YU LIN
Phone
+886983215656
Email
clouaa@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation
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