Atrial FibrillationNCT03377751

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

A study testing Additional posterior wall isolation, Voltage-guided substrate homogenization and PVI only group in people with Atrial Fibrillation, run by Korea University Guro Hospital at 3 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Additional posterior wall isolation, Voltage-guided substrate homogenization and PVI only group
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 3 sitesSouth Korea
Study dates: 15 Feb 2018to 15 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

Bucheon Sejong Hospital
Bucheon-si, 14754
Korea University Guro Hospital
Seoul, Guro-gu, 08308
Korea University Anam Hospital
Seoul, Seongbuk-gu, 02841

Other trials in South Korea

About this study

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

Read the 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.

Conditions: Atrial Fibrillation
Being tested: Additional posterior wall isolation, Voltage-guided substrate homogenization, PVI only group
Keywords: Catheter ablation, Atrial fibrillation, Low voltage area
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Additional posterior wall isolationProcedure or surgery
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).
Voltage-guided substrate homogenizationProcedure or surgery
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).
PVI only groupProcedure or surgery
PVI will be performed in this arm.

Study groups in NCT03377751
Study group	Role	What they receive
Additional posterior wall isolation	Experimental	Operator will perform pulmonary vein isolation (PVI) and additional posterior wall isolation if low voltage area exists more than 10% of the left atrium Receives: Procedure: Additional posterior wall isolation
Voltage-guided substrate homogenization	Experimental	Operator will perform pulmonary vein antrum isolation (PVI) and additional substrate modification based on the degree of low voltage area. Receives: Procedure: Voltage-guided substrate homogenization
PVI only group	Active comparator	Operator will perform PVI only Receives: Procedure: PVI only group

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201815 Dec 2019

First posted19 Dec 2017
Study start15 Feb 2018
Primary completion15 Dec 2019
Study completion15 Dec 2019

Why it stopped: Majority of enrolled patients have withdrawn.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03377751
Sponsor's protocol ID: KUGH17287 (VEGA-AF)
Status last verified: Sep 2020
First submitted: 9 Dec 2017
Last updated: 9 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Nattel S, Shiroshita-Takeshita A, Brundel BJ, Rivard L. Mechanisms of atrial fibrillation: lessons from animal models. Prog Cardiovasc Dis. 2005 Jul-Aug;48(1):9-28. doi: 10.1016/j.pcad.2005.06.002.
PubMed 16194689
Reant P, Lafitte S, Jais P, Serri K, Weerasooriya R, Hocini M, Pillois X, Clementy J, Haissaguerre M, Roudaut R. Reverse remodeling of the left cardiac chambers after catheter ablation after 1 year in a series of patients with isolated atrial fibrillation. Circulation. 2005 Nov 8;112(19):2896-903. doi: 10.1161/CIRCULATIONAHA.104.523928. Epub 2005 Oct 31.
PubMed 16260634
Cox JL, Schuessler RB, Lappas DG, Boineau JP. An 8 1/2-year clinical experience with surgery for atrial fibrillation. Ann Surg. 1996 Sep;224(3):267-73; discussion 273-5. doi: 10.1097/00000658-199609000-00003.
PubMed 8813255
Miyazaki S, Kuwahara T, Takahashi A, Kobori A, Takahashi Y, Nozato T, Hikita H, Sato A, Aonuma K, Hirao K, Isobe M. Effect of left atrial ablation on the quality of life in patients with atrial fibrillation. Circ J. 2008 Apr;72(4):582-7. doi: 10.1253/circj.72.582.
PubMed 18362429
Stabile G, Bertaglia E, Senatore G, De Simone A, Zoppo F, Donnici G, Turco P, Pascotto P, Fazzari M, Vitale DF. Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study). Eur Heart J. 2006 Jan;27(2):216-21. doi: 10.1093/eurheartj/ehi583. Epub 2005 Oct 7.
PubMed 16214831
Haegeli LM, Calkins H. Catheter ablation of atrial fibrillation: an update. Eur Heart J. 2014 Sep 21;35(36):2454-9. doi: 10.1093/eurheartj/ehu291. Epub 2014 Jul 22.
PubMed 25053659
Elayi CS, Verma A, Di Biase L, Ching CK, Patel D, Barrett C, Martin D, Rong B, Fahmy TS, Khaykin Y, Hongo R, Hao S, Pelargonio G, Dello Russo A, Casella M, Santarelli P, Potenza D, Fanelli R, Massaro R, Arruda M, Schweikert RA, Natale A. Ablation for longstanding permanent atrial fibrillation: results from a randomized study comparing three different strategies. Heart Rhythm. 2008 Dec;5(12):1658-64. doi: 10.1016/j.hrthm.2008.09.016. Epub 2008 Sep 17.
PubMed 19084800
Di Biase L, Burkhardt JD, Mohanty P, Sanchez J, Mohanty S, Horton R, Gallinghouse GJ, Bailey SM, Zagrodzky JD, Santangeli P, Hao S, Hongo R, Beheiry S, Themistoclakis S, Bonso A, Rossillo A, Corrado A, Raviele A, Al-Ahmad A, Wang P, Cummings JE, Schweikert RA, Pelargonio G, Dello Russo A, Casella M, Santarelli P, Lewis WR, Natale A. Left atrial appendage: an underrecognized trigger site of atrial fibrillation. Circulation. 2010 Jul 13;122(2):109-18. doi: 10.1161/CIRCULATIONAHA.109.928903. Epub 2010 Jul 6.
PubMed 20606120
Hayward RM, Upadhyay GA, Mela T, Ellinor PT, Barrett CD, Heist EK, Verma A, Choudhry NK, Singh JP. Pulmonary vein isolation with complex fractionated atrial electrogram ablation for paroxysmal and nonparoxysmal atrial fibrillation: A meta-analysis. Heart Rhythm. 2011 Jul;8(7):994-1000. doi: 10.1016/j.hrthm.2011.02.033. Epub 2011 Mar 10.
PubMed 21397045
Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.
PubMed 25946280
Kim JS, Shin SY, Na JO, Choi CU, Kim SH, Kim JW, Kim EJ, Rha SW, Park CG, Seo HS, Oh DJ, Hwang C, Lim HE. Does isolation of the left atrial posterior wall improve clinical outcomes after radiofrequency catheter ablation for persistent atrial fibrillation?: A prospective randomized clinical trial. Int J Cardiol. 2015 Feb 15;181:277-83. doi: 10.1016/j.ijcard.2014.12.035. Epub 2014 Dec 11.
PubMed 25535691
Han SW, Shin SY, Im SI, Na JO, Choi CU, Kim SH, Kim JW, Kim EJ, Rha SW, Park CG, Seo HS, Oh DJ, Hwang C, Lim HE. Does the amount of atrial mass reduction improve clinical outcomes after radiofrequency catheter ablation for long-standing persistent atrial fibrillation? Comparison between linear ablation and defragmentation. Int J Cardiol. 2014 Jan 15;171(1):37-43. doi: 10.1016/j.ijcard.2013.11.041. Epub 2013 Nov 23.
PubMed 24315152
Gibson DN, Di Biase L, Mohanty P, Patel JD, Bai R, Sanchez J, Burkhardt JD, Heywood JT, Johnson AD, Rubenson DS, Horton R, Gallinghouse GJ, Beheiry S, Curtis GP, Cohen DN, Lee MY, Smith MR, Gopinath D, Lewis WR, Natale A. Stiff left atrial syndrome after catheter ablation for atrial fibrillation: clinical characterization, prevalence, and predictors. Heart Rhythm. 2011 Sep;8(9):1364-71. doi: 10.1016/j.hrthm.2011.02.026. Epub 2011 Feb 23.
PubMed 21354332
Wu SH, Jiang WF, Gu J, Zhao L, Wang YL, Liu YG, Zhou L, Gu JN, Xu K, Liu X. Benefits and risks of additional ablation of complex fractionated atrial electrograms for patients with atrial fibrillation: a systematic review and meta-analysis. Int J Cardiol. 2013 Oct 25;169(1):35-43. doi: 10.1016/j.ijcard.2013.08.083. Epub 2013 Sep 7.
PubMed 24083885
Kim JS, Im SI, Shin SY, Kang JH, Na JO, Choi CU, Kim SH, Kim EJ, Rha SW, Park CG, Seo HS, Oh DJ, Hwang C, Kim YH, Yong HS, Lim HE. Changes in Left Atrial Transport Function in Patients Who Maintained Sinus Rhythm After Successful Radiofrequency Catheter Ablation for Atrial Fibrillation: A 1-Year Follow-Up Multislice Computed Tomography Study. J Cardiovasc Electrophysiol. 2017 Feb;28(2):167-176. doi: 10.1111/jce.13128. Epub 2016 Dec 15.
PubMed 27859888

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does VoltagE Guided Additional Ablation Improve Procedural Outcome of Atrial Fibrillation Ablation? (The VEGA-AF Study)
ClinicalTrials.gov ID: NCT03377751
Acronym / sponsor ID: KUGH17287 (VEGA-AF)
Conditions: Atrial Fibrillation
Keywords: Catheter ablation, Atrial fibrillation, Low voltage area
Study type: Interventional
Recruitment status: TerminatedReason stopped: Majority of enrolled patients have withdrawn.
Enrolment: 20 participants (actual)
Lead sponsor: Korea University Guro HospitalUniversity, hospital or other
Study start: 15 Feb 2018 (actual)
Primary completion: 15 Dec 2019 (actual)
Study completion: 15 Dec 2019 (actual)
First posted: 19 Dec 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Additional posterior wall isolation	Experimental	Procedure: Additional posterior wall isolationOperator will perform pulmonary vein isolation (PVI) and additional posterior wall isolation if low voltage area exists more than 10% of the left atrium
Voltage-guided substrate homogenization	Experimental	Procedure: Voltage-guided substrate homogenizationOperator will perform pulmonary vein antrum isolation (PVI) and additional substrate modification based on the degree of low voltage area.
PVI only group	Active comparator	Procedure: PVI only groupOperator will perform PVI only

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Additional posterior wall isolationPVI 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).	Procedure or surgery	Additional posterior wall isolation
Voltage-guided substrate homogenizationPVI 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).	Procedure or surgery	Voltage-guided substrate homogenization
PVI only groupPVI will be performed in this arm.	Procedure or surgery	PVI only group

Primary outcome

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.

2 secondary outcomes

Procedure related complication rate
Time frame: during procedure and follow-up period(up to 1 year)
Total procedural time
Time frame: During procedure

Results and safety

The study was stopped early (reason given: Majority of enrolled patients have withdrawn.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
Background: PubMed 16194689Nattel S, Shiroshita-Takeshita A, Brundel BJ, Rivard L. Mechanisms of atrial fibrillation: lessons from animal models. Prog Cardiovasc Dis. 2005 Jul-Aug;48(1):9-28. doi: 10.1016/j.pcad.2005.06.002.
Background: PubMed 16260634Reant P, Lafitte S, Jais P, Serri K, Weerasooriya R, Hocini M, Pillois X, Clementy J, Haissaguerre M, Roudaut R. Reverse remodeling of the left cardiac chambers after catheter ablation after 1 year in a series of patients with isolated atrial fibrillation. Circulation. 2005 Nov 8;112(19):2896-903. doi: 10.1161/CIRCULATIONAHA.104.523928. Epub 2005 Oct 31.
Background: PubMed 8813255Cox JL, Schuessler RB, Lappas DG, Boineau JP. An 8 1/2-year clinical experience with surgery for atrial fibrillation. Ann Surg. 1996 Sep;224(3):267-73; discussion 273-5. doi: 10.1097/00000658-199609000-00003.
Background: PubMed 18362429Miyazaki S, Kuwahara T, Takahashi A, Kobori A, Takahashi Y, Nozato T, Hikita H, Sato A, Aonuma K, Hirao K, Isobe M. Effect of left atrial ablation on the quality of life in patients with atrial fibrillation. Circ J. 2008 Apr;72(4):582-7. doi: 10.1253/circj.72.582.
Background: PubMed 16214831Stabile G, Bertaglia E, Senatore G, De Simone A, Zoppo F, Donnici G, Turco P, Pascotto P, Fazzari M, Vitale DF. Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study). Eur Heart J. 2006 Jan;27(2):216-21. doi: 10.1093/eurheartj/ehi583. Epub 2005 Oct 7.
Background: PubMed 25053659Haegeli LM, Calkins H. Catheter ablation of atrial fibrillation: an update. Eur Heart J. 2014 Sep 21;35(36):2454-9. doi: 10.1093/eurheartj/ehu291. Epub 2014 Jul 22.
Background: PubMed 19084800Elayi CS, Verma A, Di Biase L, Ching CK, Patel D, Barrett C, Martin D, Rong B, Fahmy TS, Khaykin Y, Hongo R, Hao S, Pelargonio G, Dello Russo A, Casella M, Santarelli P, Potenza D, Fanelli R, Massaro R, Arruda M, Schweikert RA, Natale A. Ablation for longstanding permanent atrial fibrillation: results from a randomized study comparing three different strategies. Heart Rhythm. 2008 Dec;5(12):1658-64. doi: 10.1016/j.hrthm.2008.09.016. Epub 2008 Sep 17.
Background: PubMed 20606120Di Biase L, Burkhardt JD, Mohanty P, Sanchez J, Mohanty S, Horton R, Gallinghouse GJ, Bailey SM, Zagrodzky JD, Santangeli P, Hao S, Hongo R, Beheiry S, Themistoclakis S, Bonso A, Rossillo A, Corrado A, Raviele A, Al-Ahmad A, Wang P, Cummings JE, Schweikert RA, Pelargonio G, Dello Russo A, Casella M, Santarelli P, Lewis WR, Natale A. Left atrial appendage: an underrecognized trigger site of atrial fibrillation. Circulation. 2010 Jul 13;122(2):109-18. doi: 10.1161/CIRCULATIONAHA.109.928903. Epub 2010 Jul 6.
Background: PubMed 21397045Hayward RM, Upadhyay GA, Mela T, Ellinor PT, Barrett CD, Heist EK, Verma A, Choudhry NK, Singh JP. Pulmonary vein isolation with complex fractionated atrial electrogram ablation for paroxysmal and nonparoxysmal atrial fibrillation: A meta-analysis. Heart Rhythm. 2011 Jul;8(7):994-1000. doi: 10.1016/j.hrthm.2011.02.033. Epub 2011 Mar 10.
Background: PubMed 25946280Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.
Background: PubMed 25535691Kim JS, Shin SY, Na JO, Choi CU, Kim SH, Kim JW, Kim EJ, Rha SW, Park CG, Seo HS, Oh DJ, Hwang C, Lim HE. Does isolation of the left atrial posterior wall improve clinical outcomes after radiofrequency catheter ablation for persistent atrial fibrillation?: A prospective randomized clinical trial. Int J Cardiol. 2015 Feb 15;181:277-83. doi: 10.1016/j.ijcard.2014.12.035. Epub 2014 Dec 11.
Background: PubMed 24315152Han SW, Shin SY, Im SI, Na JO, Choi CU, Kim SH, Kim JW, Kim EJ, Rha SW, Park CG, Seo HS, Oh DJ, Hwang C, Lim HE. Does the amount of atrial mass reduction improve clinical outcomes after radiofrequency catheter ablation for long-standing persistent atrial fibrillation? Comparison between linear ablation and defragmentation. Int J Cardiol. 2014 Jan 15;171(1):37-43. doi: 10.1016/j.ijcard.2013.11.041. Epub 2013 Nov 23.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hong Euy Lim, MD, Ph.D. principal investigator

Professor

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Majority of enrolled patients have withdrawn.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom rate of any atrial tachy-arrhythmia during 1 year after ablation procedure (time frame: Within 1 year after the ablation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03377751, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.