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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)
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

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

Exclusion Criteria:

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

Sites / Locations

  • Wen-Chin TsaiRecruiting

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 & ventricular systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF. Measurements: LAD [left atrial diameter]
LVEF
Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and atrial & ventricular systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF. Measurements: LVEF [left ventricular ejection fraction]
e/e'
Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and atrial & ventricular systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF. Measurements: e/e' [the ratio of early diastolic mitral inflow velocity to early diastolic mitral annulus velocity]

Full Information

First Posted
May 15, 2022
Last Updated
June 21, 2022
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05426603
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
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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.
Time Frame
Baseline and 3, 6, 9 and 12 months after catheter-based ablation of atrial fibrillation
Secondary Outcome Measure Information:
Title
LAD
Description
Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and atrial & ventricular systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF. Measurements: LAD [left atrial diameter]
Time Frame
after catheter ablation of atrial fibrillation 3, 6, 12 month
Title
LVEF
Description
Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and atrial & ventricular systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF. Measurements: LVEF [left ventricular ejection fraction]
Time Frame
after catheter ablation of atrial fibrillation 3, 6, 12 month
Title
e/e'
Description
Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and atrial & ventricular systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF. Measurements: e/e' [the ratio of early diastolic mitral inflow velocity to early diastolic mitral annulus velocity]
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
No
Eligibility Criteria
Inclusion Criteria: Patients 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
Email
qqsnoopy0223@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yenn-Jiang Lin, MD, PhD
Facility Information:
Facility Name
Wen-Chin Tsai
City
Hualien City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Chin Tsai, PhD
Phone
+886 0905292666
Email
wenchintsai38@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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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