- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05426603
Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation
A Randomized Controlled Study on the Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chia-Hsin Chiang
- Phone Number: 1189 +886-2-28712121
- Email: qqsnoopy0223@gmail.com
Study Contact Backup
- Name: Yenn-Jiang Lin, MD, PhD
Study Locations
-
-
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Hualien City, Taiwan
- Recruiting
- Wen-Chin Tsai
-
Contact:
- Wen-Chin Tsai, PhD
- Phone Number: +886 0905292666
- Email: wenchintsai38@gmail.com
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pulmonary vein isolation + Waveform Periodicity Group
Pulmonary vein isolation + Substrate ablation
|
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.
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
|
Other: Pulmonary vein isolation group
Pulmonary vein isolation (Conventional treatment)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation
Time Frame: Baseline and 3, 6, 9 and 12 months 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. |
Baseline and 3, 6, 9 and 12 months after catheter-based ablation of atrial fibrillation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LAD
Time Frame: after catheter ablation of atrial fibrillation 3, 6, 12 month
|
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] |
after catheter ablation of atrial fibrillation 3, 6, 12 month
|
LVEF
Time Frame: after catheter ablation of atrial fibrillation 3, 6, 12 month
|
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] |
after catheter ablation of atrial fibrillation 3, 6, 12 month
|
e/e'
Time Frame: after catheter ablation of atrial fibrillation 3, 6, 12 month
|
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] |
after catheter ablation of atrial fibrillation 3, 6, 12 month
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-109-249-B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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