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Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation

Primary Purpose

Atrial Fibrillation, Persistent

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Pulmonary vein isolation

Substrate ablation(PRISM based)

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation, Persistent focused on measuring Catheter ablation, Mapping technique, Substrate mapping, Non-linear electrogram morphology analysis

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patents who sign the informed consent forms, and allow to be followed.
Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication.
Patients with persistent/permanent AF (sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion).
Patients with age equal or greater than 20 years old regardless of gender.

Exclusion Criteria:

The presence of a atrial or ventricular thrombus.
Patients who are allergic to or unsuitable for use with the contrast media.
Pregnant patients or patients who are unavailable to receive X-ray.
Patients with renal insufficiency.
Patients had autonomic nervous system disorder (e.g. respiratory apnea) or previous catheter ablation in the LA or MAZE procedure.
Patients who do not need atrial substrate modification (patients with non-paroxysmal AF respond to PVI in terms of procedural termination of AF).
Patients with age less than 20 years old or greater than 90 years old regardless of gender.

Sites / Locations

Taipei General Veterans HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Pulmonary vein isolation + Waveform Periodicity Group

Pulmonary vein isolation group

Arm Description

Pulmonary vein isolation + Substrate ablation

Pulmonary vein isolation (Conventional treatment)

Outcomes

Primary Outcome Measures

changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation

A 24-hour Holter monitoring and/or ECG (7 days recordings) will be performed at 3, 6, 9, and 12 months post ablation and/or when the patients experience symptoms suggestive of a tachycardia after the ablation. Measurements: documentation of AF signal duration more than 30 seconds.

Secondary Outcome Measures

LAD

Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and atrial systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF. LAD [left atrial diameter]

LVEF

Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and ventricular systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF. LVEF [left ventricular ejection fraction]

e/e'

Full Information

NCT ID

NCT05333952

First Posted

April 1, 2022

Last Updated

June 1, 2022

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT05333952

Brief Title

Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 19, 2019 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Atrial fibrillation (AF) has been the most frequently occurring, sustained arrhythmia, which causes significant morbidity and mortality. AF may not always be a totally random process. It can be maintained by stable and rapid reentrant circuits resulting in fibrillary conduction throughout the atria. During mapping of AF, difficulty is frequently encountered during the identification of culprit sites and an analysis of the wave propagation particularly when the electrogram signals demonstrate wide temporal and spatial disparities. Catheter ablation targeting regions with fractionated potentials or high frequencies during AF, has been previously proposed as a treatment strategy. However, the benefit of adjunctive CFAE (complex fractionated atrial electrogram) ablation or linear ablation after successful PVI (pulmonary vein isolation) was controversial based on the recent data from the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II (STAR AF II) trial. Therefore, the optimal ablation strategy for persistent AF remains undetermined and an alternative approach has to be explored.

Detailed Description

In this prospective trial, investigators will investigate the long-term efficacy of catheter ablation of non-paroxysmal AF, based on selective atrial substrate modification (e.g. wavefrom periodicity analysis, similarity, plus phase mapping) (1). The control group would be PV isolation alone. The primary end point is long-term recurrence of atrial arrhythmias. The secondary end points composite procedural termination, the safety of the procedure, recurrence of multiple procedures, and change of atrial and ventricular function after catheter ablation. The inclusion criteria, exclusion criteria, stepwise catheter ablation procedures (PVI and then substrate modification), and the follow-up procedure are the same as current treatment approaches in patients with non-paroxysmal AF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Persistent

Keywords

Catheter ablation, Mapping technique, Substrate mapping, Non-linear electrogram morphology analysis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pulmonary vein isolation + Waveform Periodicity Group

Arm Type

Experimental

Arm Description

Pulmonary vein isolation + Substrate ablation

Arm Title

Pulmonary vein isolation group

Arm Type

Other

Arm Description

Pulmonary vein isolation (Conventional treatment)

Intervention Type

Procedure

Intervention Name(s)

Pulmonary vein isolation

Intervention Description

The 3D geometry of the LA will be created using CARTO 3 system (version 6) with UDM Module and VISITAG Optimum Device Performance (ODP) module. Continuous circumferential lesions will then be created encircling the right and left PV ostia using a 7.5F, 3.5-mm Thermocool SMARTTOUCH ablation catheter (Biosense Webster, Inc., Diamond Bar, CA, USA).Pentaray catheter will be used and facilitate the high density mapping of atrial substrate (PentarayTM, Biosense Webster Inc., Diamond Bar, CA, USA). The radiofrequency energy will be applied with contact force range 5-25 g continuously with a target Ablation Index target 380-400 on the posterior wall and 550 - 600 on the anterior wall and maximum power of 25-35W in a power control mode.

Intervention Type

Procedure

Intervention Name(s)

Substrate ablation(PRISM based)

Intervention Description

Substrate modification will be guided by waveform periodicity analysis. The User Defined Map of waveform periodicity analysis will be also created by CARTO 3 system (version 6) with and VISITAG ODP module. Pentaray catheter will be used and facilitate the high density mapping of atrial substrate (PentarayTM, Biosense Webster Inc., Diamond Bar, CA, USA). Substrate modification based on waveform periodicity analysis will be performed by using a 7.5F, 3.5-mm Thermocool SMARTTOUCH ablation catheter (Biosense Webster, Inc., Diamond Bar, CA, USA). The radiofrequency energy will be applied with contact force range 5-25 g continuously with a target Ablation Index target 380-400 on the posterior wall and 550 - 600 on the anterior wall and maximum power of 25-35W in a power control mode.

Primary Outcome Measure Information:

Title

changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation

Description

Time Frame

Baseline and 3, 6, 9 and 12 months after catheter-based ablation of atrial fibrillation

Secondary Outcome Measure Information:

Title

LAD

Description

Time Frame

after catheter ablation of atrial fibrillation 3, 6, 12 month

Title

LVEF

Description

Time Frame

after catheter ablation of atrial fibrillation 3, 6, 12 month

Title

e/e'

Description

Time Frame

after catheter ablation of atrial fibrillation 3, 6, 12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patents who sign the informed consent forms, and allow to be followed. Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication. Patients with persistent/permanent AF (sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion). Patients with age equal or greater than 20 years old regardless of gender. Exclusion Criteria: The presence of a atrial or ventricular thrombus. Patients who are allergic to or unsuitable for use with the contrast media. Pregnant patients or patients who are unavailable to receive X-ray. Patients with renal insufficiency. Patients had autonomic nervous system disorder (e.g. respiratory apnea) or previous catheter ablation in the LA or MAZE procedure. Patients who do not need atrial substrate modification (patients with non-paroxysmal AF respond to PVI in terms of procedural termination of AF). Patients with age less than 20 years old or greater than 90 years old regardless of gender.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chia-Hsin Chiang

Phone

+886-2-28712121

Ext

1189

qqsnoopy0223@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yenn-Jiang Lin, MD, PhD

Organizational Affiliation

Director of Cardiology Division of Taipei Veterans General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taipei General Veterans Hospital

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yenn-Jiang Lin, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The patient's data was available to the host of IRB.

Citations:

PubMed Identifier

33998256

Citation

Lin CY, Lin YJ, Lo MT, Chiang CH, Chen YY, Kuo L, Chang SL, Lo LW, Hu YF, Chao TF, Chung FP, Liao JN, Chang TY, Lin C, Tuan TC, Wu CI, Liu CM, Liu SH, Cheng WH, Lugtu IC, Jain A, Ton AN, Hermanto DY, Chen SA. Efficacy of Patient-Specific Strategy: Catheter Ablation Strategy of Persistent Atrial Fibrillation Based on Morphological Repetitiveness by Periodicity and Similarity. Circ Arrhythm Electrophysiol. 2021 May;14(5):e009719. doi: 10.1161/CIRCEP.121.009719. Epub 2021 May 17. No abstract available.

Results Reference

result

PubMed Identifier

33825268

Citation

Hsieh YC, Lin YJ, Lo MT, Chen YY, Lin CY, Lin C, Chung FP, Lo LW, Chang SL, Chao TF, Hu YF, Tuan TC, Liao JN, Wu CI, Liu CM, Vicera JB, Chen CC, Chin CG, Lugtu IC, Chen SA. Optimal substrate modification strategies using catheter ablation in patients with persistent atrial fibrillation: 3-year follow-up outcomes. J Cardiovasc Electrophysiol. 2021 Jun;32(6):1561-1571. doi: 10.1111/jce.15033. Epub 2021 May 5.

Results Reference

result

PubMed Identifier

30536679

Citation

Lin CY, Lin YJ, Narayan SM, Baykaner T, Lo MT, Chung FP, Chen YY, Chang SL, Lo LW, Hu YF, Liao JN, Tuan TC, Chao TF, Te ALD, Kuo L, Vicera JJB, Chang TY, Salim S, Chien KL, Chen SA. Comparison of phase mapping and electrogram-based driver mapping for catheter ablation in atrial fibrillation. Pacing Clin Electrophysiol. 2019 Feb;42(2):216-223. doi: 10.1111/pace.13573. Epub 2018 Dec 27.

Results Reference

result

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Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation

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