Does VoltagE Guided Additional Ablation Improve Procedural Outcome of Atrial Fibrillation Ablation?

Sponsor

Korea University Guro Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT03377751

Collaborator

(none)

Enrollment

Locations

Arms

21.9

Actual Duration (Months)

6.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to investigate whether pulmonary vein isolation(PVI) plus stepwise additional ablation approach based on the degree of low voltage area versus PVI only can improve procedure outcome in persistent atrial fibrillation(AF) patients.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: Additional posterior wall isolation Procedure: Voltage-guided substrate homogenization Procedure: PVI only group	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Does VoltagE Guided Additional Ablation Improve Procedural Outcome of Atrial Fibrillation Ablation? (The VEGA-AF Study)

Actual Study Start Date :

Feb 15, 2018

Actual Primary Completion Date :

Dec 15, 2019

Actual Study Completion Date :

Dec 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
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. Proportion of low voltage area to area of left atrium body <10% : PVI only Proportion of low voltage area to area of left atrium body ≥10% : PVI + Posterior wall isolation Low voltage area will be measured from more than 1000 points of sampled voltage value during sinus rhythm using PentaRay catheter with 3D mapping system of CARTO (Biosense Webster, CA, USA).
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. Proportion of low voltage area to area of left atrium body <10% : PVI only Proportion of low voltage area to area of left atrium body ≥10% : PVI + substrate homogenization at low voltage areas Low voltage area will be measured from more than 1000 points of sampled voltage value during sinus rhythm using PentaRay catheter with 3D mapping system of CARTO (Biosense Webster, CA, USA).
Active Comparator: PVI only group Operator will perform PVI only	Procedure: PVI only group PVI will be performed in this arm.

Arm

Intervention/Treatment

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. Proportion of low voltage area to area of left atrium body <10% : PVI only Proportion of low voltage area to area of left atrium body ≥10% : PVI + Posterior wall isolation Low voltage area will be measured from more than 1000 points of sampled voltage value during sinus rhythm using PentaRay catheter with 3D mapping system of CARTO (Biosense Webster, CA, USA).

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. Proportion of low voltage area to area of left atrium body <10% : PVI only Proportion of low voltage area to area of left atrium body ≥10% : PVI + substrate homogenization at low voltage areas Low voltage area will be measured from more than 1000 points of sampled voltage value during sinus rhythm using PentaRay catheter with 3D mapping system of CARTO (Biosense Webster, CA, USA).

Active Comparator: PVI only group

Operator will perform PVI only

Procedure: PVI only group

PVI will be performed in this arm.

Outcome Measures

Primary Outcome Measures

Freedom rate of any atrial tachy-arrhythmia during 1 year after ablation procedure [Within 1 year after the ablation procedure]
Any recurrence of ECG or Holter documented atrial tachyarrhythmia* * Sustained AF or atrial tachycardia >30 s duration.

Secondary Outcome Measures

Procedure related complication rate [during procedure and follow-up period(up to 1 year)]
any adverse events
Total procedural time [During procedure]
total cumulative amount of radiation exposure

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing first-time catheter ablation for AF.
Willing and able to provide informed consent
Age greater than or equal to 18 years.

Exclusion Criteria:

Patients who have previously undergone AF ablation
Patients with more than mild mitral valve stenosis or mechanical mitral valve replacement
Patients with chronic renal impairment with creatinine clearance rate of <30 mL/min
Patients who are pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Guro Hospital	Seoul	Guro-gu	Korea, Republic of	08308
2	Korea University Anam Hospital	Seoul	Seongbuk-gu	Korea, Republic of	02841
3	Bucheon Sejong Hospital	Bucheon		Korea, Republic of	14754

Sponsors and Collaborators

Korea University Guro Hospital

Investigators

Principal Investigator: Hong Euy Lim, MD, Ph.D., Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Hong Euy Lim, MD, Professor, Korea University Guro Hospital

ClinicalTrials.gov Identifier:

NCT03377751

Other Study ID Numbers:

KUGH17287 (VEGA-AF)

First Posted:

Dec 19, 2017

Last Update Posted:

Sep 9, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hong Euy Lim, MD, Professor, Korea University Guro Hospital

Catheter ablation

Atrial fibrillation

Low voltage area

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Sep 9, 2020