Waveform Periodicity Analysis in Patients With Persistent... | NCT06023888

Studies
Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation

NCT06023888

Sponsor

Taipei Veterans General Hospital, Taiwan

Status

Recruiting

Last Update Posted

Oct 17, 2024Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

Mapping strategy
Mapping strategy

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 9, 2023Actual

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Aug 29, 2023

First Submission Date that Met QC Criteria

Sep 4, 2023

First Posted Date

Sep 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2024

Last Update Posted Date

Oct 17, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chin-Yu Lin, Doctor, Taipei Veterans General Hospital, TaiwanPrincipal Investigator

Lead Sponsor

Taipei Veterans General Hospital, TaiwanOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Periodicity-based	Experimental		Other: Mapping strategy
Control	Other	Standard ablation strategy as usual	Other: Mapping strategy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mapping strategy	Other	The ablation strategy was based on the mapping results of periodicity.	Periodicity-based

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
CHIN-YU LIN, DR	Contact	+886983215656		clouaa@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Veterans General Hospital	Recruiting	Taipei		112	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.