Does VoltagE Guided Additional Ablation Improve Procedural Outcome of Atrial Fibrillation Ablation?
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|ClinicalTrials.gov Identifier: NCT03377751|
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Procedure: Additional posterior wall isolation Procedure: Voltage-guided substrate homogenization Procedure: PVI only group||Not Applicable|
Catheter ablation of AF is well accepted and widely performing treatment method of AF at present. Pulmonary vein isolation (PVI) which aims to electrical isolation of pulmonary veins is currently the standard therapy for AF. But some researchers proposed additional ablation strategy for persistent AF (PeAF) because abnormal atrial substrate may play a role in these patients.
However, there are inconsistent reports regarding a success rate of additional catheter ablation methods other than PVI. Thus, there still is no consensus on which strategy is appropriate in addition to PVI. One of these proposed options is complex fractioned atrial electrograms (CFAE) ablation. A meta-analysis of controlled trials comparing PVI alone versus PVI with CFAE reported that the addition of CFAE ablation results in a statistically significant increase in success rate for PeAF patients. Conversely, a prospective multicenter trial, The Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II (STAR-AF II) trial showed that recurrence rate of AF following catheter ablation treatment was not significantly reduced when either linear ablation or ablation of CFAE was performed in addition to PVI. The investigators have previously reported that posterior wall isolation in addition to PVI plus linear lesions reduced recurrence of AF following catheter ablation compared to PVI only but the long-term success rate were markedly lower in the CFAE-guide ablation in addition PVI plus linear lesions group than in PVI plus linear lesions group among PeAF patients. Although benefit of addition CFAE could be originated from modification of abnormal atrial substrate which is generated by structural and electrical remodeling, this possible benefit could be counterbalanced by increased formation of transmural ablation scar which may result in dysfunction of left atrium and recurrence of atrial tachyarrhythmia. A recent study have showed that extent of myocardial injury by catheter ablation was associated with left atrium functional deterioration in patients with paroxysmal AF and myocardial damage provoked that may contribute to recurrence of AF following catheter ablation.
Therefore, identification of PeAF patients who would benefit from additional ablation and tailored stepwise approach based on the identification may lead to reduction of iatrogenic myocardial injury and optimization of the result for the AF catheter ablation.
Recent data have shown that voltage guided mapping of left atrium is a powerful predictor of AF recurrence after PAI and voltage based ablation strategy showed promising result in terms of tailored approach. But, prospective, randomized clinical studies are needed to compare the result of a voltage-based AF ablation to the result of established strategies.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Does VoltagE Guided Additional Ablation Improve Procedural Outcome of Atrial Fibrillation Ablation? (The VEGA-AF Study)|
|Actual Study Start Date :||February 15, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Additional posterior wall isolation
Operator will perform pulmonary vein isolation (PVI) and additional posterior wall isolation if low voltage area exists more than 10% of the left atrium
Procedure: Additional posterior wall isolation
PVI and additional posterior wall isolation will be performed according to the following protocol which is based on low voltage area.
Experimental: Voltage-guided substrate homogenization
Operator will perform pulmonary vein antrum isolation (PVI) and additional substrate modification based on the degree of low voltage area.
Procedure: Voltage-guided substrate homogenization
PVI and additional substrate modification at low voltage areas will be performed according to the following protocol which is based on low voltage area.
Active Comparator: PVI only group
Operator will perform PVI only
Procedure: PVI only group
PVI will be performed in this arm.
- Freedom rate of any atrial tachy-arrhythmia during 1 year after ablation procedure [ Time Frame: Within 1 year after the ablation procedure ]
Any recurrence of ECG or Holter documented atrial tachyarrhythmia*
* Sustained AF or atrial tachycardia >30 s duration.
- Procedure related complication rate [ Time Frame: during procedure and follow-up period(up to 1 year) ]any adverse events
- Total procedural time [ Time Frame: During procedure ]total cumulative amount of radiation exposure
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377751
|Contact: Hong Euy Lim, MD, Ph.D.||firstname.lastname@example.org|
|Contact: Do Young Kim, MDemail@example.com|
|Korea, Republic of|
|Korea University Guro Hospital||Recruiting|
|Seoul, Guro-gu, Korea, Republic of, 08308|
|Contact: Seung-hoe Song, MBE 82-2-2626-1635 firstname.lastname@example.org|
|Korea University Anam Hospital||Recruiting|
|Seoul, Seongbuk-gu, Korea, Republic of, 02841|
|Contact: Jaemin Shim, MD, Ph.D.|
|Principal Investigator: Jaemin Shim, MD, Ph.D.|
|Bucheon Sejong Hospital||Not yet recruiting|
|Bucheon, Korea, Republic of, 14754|
|Contact: Sang Weon Park, MD, PhD|
|Principal Investigator: Sang Weon Park, MD, PhD|
|Principal Investigator:||Hong Euy Lim, MD, Ph.D.||Professor|