Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377751
Recruitment Status : Terminated (Majority of enrolled patients have withdrawn.)
First Posted : December 19, 2017
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Hong Euy Lim, MD, Korea University Guro Hospital

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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : February 15, 2018
Actual Primary Completion Date : December 15, 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


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.

  1. Proportion of low voltage area to area of left atrium body <10% : PVI only
  2. 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.

  1. Proportion of low voltage area to area of left atrium body <10% : PVI only
  2. 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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Procedure related complication rate [ Time Frame: during procedure and follow-up period(up to 1 year) ]
    any adverse events

  2. Total procedural time [ Time Frame: During procedure ]
    total cumulative amount of radiation exposure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377751


Locations
Layout table for location information
Korea, Republic of
Korea University Guro Hospital
Seoul, Guro-gu, Korea, Republic of, 08308
Korea University Anam Hospital
Seoul, Seongbuk-gu, Korea, Republic of, 02841
Bucheon Sejong Hospital
Bucheon, Korea, Republic of, 14754
Sponsors and Collaborators
Korea University Guro Hospital
Investigators
Layout table for investigator information
Principal Investigator: Hong Euy Lim, MD, Ph.D. Professor
Publications:

Layout table for additonal information
Responsible Party: Hong Euy Lim, MD, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT03377751    
Other Study ID Numbers: KUGH17287 (VEGA-AF)
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hong Euy Lim, MD, Korea University Guro Hospital:
Catheter ablation
Atrial fibrillation
Low voltage area
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes