NCT02814136

Brief Summary

Ablation of atrial fibrillation is an established method for treatment of subjects with atrial fibrillation with goal of restoration of sinus rhythm. Among different methods, wide area circular ablation (WACA) is shown to provide the same results with fewer complications. This project will compare WACA with extra-wide area circular ablation (E-WACA) in subjects who are considered for ablation of atrial fibrillation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

5 years

First QC Date

June 22, 2016

Last Update Submit

August 29, 2019

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • To evaluate the achievement of sinus rhythm in subjects undergoing ablation of atrial fibrillation using WACA compared to E-WACA.

    1 year

Secondary Outcomes (1)

  • ii. To compare the time to reoccurrence of atrial fibrillation, atrial flutter and/or atrial tachycardia in subjects undergoing ablation of atrial fibrillation using WACA compared to E-WACA.

    1 year

Other Outcomes (1)

  • iii. To assess the frequency of complications in subjects undergoing ablation of atrial fibrillation using WACA compare to E-WACA.

    1 year

Study Arms (2)

WACA

ACTIVE COMPARATOR

wide area circular ablation

Procedure: Ablation

EWACA

ACTIVE COMPARATOR

extra-wide area circular ablation

Procedure: Ablation

Interventions

AblationPROCEDURE
EWACAWACA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects with symptomatic persistent atrial fibrillation who are scheduled for clinically indicated ablation of AF.

You may not qualify if:

  • Subjects younger than 18 year of age.
  • Subjects who are pregnant.
  • Subjects who are unable to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mosaic Life Care

Saint Joseph, Missouri, 64506, United States

RECRUITING

Related Publications (11)

  • Kumagai K, Ogawa M, Noguchi H, Yasuda T, Nakashima H, Saku K. Electrophysiologic properties of pulmonary veins assessed using a multielectrode basket catheter. J Am Coll Cardiol. 2004 Jun 16;43(12):2281-9. doi: 10.1016/j.jacc.2004.01.051.

    PMID: 15193694BACKGROUND

  • Jongbloed MR, Schalij MJ, Poelmann RE, Blom NA, Fekkes ML, Wang Z, Fishman GI, Gittenberger-De Groot AC. Embryonic conduction tissue: a spatial correlation with adult arrhythmogenic areas. J Cardiovasc Electrophysiol. 2004 Mar;15(3):349-55. doi: 10.1046/j.1540-8167.2004.03487.x.

    PMID: 15030427BACKGROUND

  • Perez-Lugones A, McMahon JT, Ratliff NB, Saliba WI, Schweikert RA, Marrouche NF, Saad EB, Navia JL, McCarthy PM, Tchou P, Gillinov AM, Natale A. Evidence of specialized conduction cells in human pulmonary veins of patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2003 Aug;14(8):803-9. doi: 10.1046/j.1540-8167.2003.03075.x.

    PMID: 12890038BACKGROUND

  • Vaitkevicius R, Saburkina I, Rysevaite K, Vaitkeviciene I, Pauziene N, Zaliunas R, Schauerte P, Jalife J, Pauza DH. Nerve supply of the human pulmonary veins: an anatomical study. Heart Rhythm. 2009 Feb;6(2):221-8. doi: 10.1016/j.hrthm.2008.10.027. Epub 2008 Oct 22.

    PMID: 19187915BACKGROUND

  • Ouyang F, Bansch D, Ernst S, Schaumann A, Hachiya H, Chen M, Chun J, Falk P, Khanedani A, Antz M, Kuck KH. Complete isolation of left atrium surrounding the pulmonary veins: new insights from the double-Lasso technique in paroxysmal atrial fibrillation. Circulation. 2004 Oct 12;110(15):2090-6. doi: 10.1161/01.CIR.0000144459.37455.EE. Epub 2004 Oct 4.

    PMID: 15466640BACKGROUND

  • Pappone C, Rosanio S, Augello G, Gallus G, Vicedomini G, Mazzone P, Gulletta S, Gugliotta F, Pappone A, Santinelli V, Tortoriello V, Sala S, Zangrillo A, Crescenzi G, Benussi S, Alfieri O. Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation: outcomes from a controlled nonrandomized long-term study. J Am Coll Cardiol. 2003 Jul 16;42(2):185-97. doi: 10.1016/s0735-1097(03)00577-1.

    PMID: 12875749BACKGROUND

  • Pappone C, Santinelli V, Manguso F, Vicedomini G, Gugliotta F, Augello G, Mazzone P, Tortoriello V, Landoni G, Zangrillo A, Lang C, Tomita T, Mesas C, Mastella E, Alfieri O. Pulmonary vein denervation enhances long-term benefit after circumferential ablation for paroxysmal atrial fibrillation. Circulation. 2004 Jan 27;109(3):327-34. doi: 10.1161/01.CIR.0000112641.16340.C7. Epub 2004 Jan 5.

    PMID: 14707026BACKGROUND

  • Arentz T, Weber R, Burkle G, Herrera C, Blum T, Stockinger J, Minners J, Neumann FJ, Kalusche D. Small or large isolation areas around the pulmonary veins for the treatment of atrial fibrillation? Results from a prospective randomized study. Circulation. 2007 Jun 19;115(24):3057-63. doi: 10.1161/CIRCULATIONAHA.107.690578. Epub 2007 Jun 11.

    PMID: 17562956BACKGROUND

  • Chae S, Oral H, Good E, Dey S, Wimmer A, Crawford T, Wells D, Sarrazin JF, Chalfoun N, Kuhne M, Fortino J, Huether E, Lemerand T, Pelosi F, Bogun F, Morady F, Chugh A. Atrial tachycardia after circumferential pulmonary vein ablation of atrial fibrillation: mechanistic insights, results of catheter ablation, and risk factors for recurrence. J Am Coll Cardiol. 2007 Oct 30;50(18):1781-7. doi: 10.1016/j.jacc.2007.07.044. Epub 2007 Oct 15.

    PMID: 17964043BACKGROUND

  • Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D; Heart Rhythm Society Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society. Heart Rhythm. 2012 Apr;9(4):632-696.

    BACKGROUND

  • Tamborero D, Mont L, Berruezo A, Matiello M, Benito B, Sitges M, Vidal B, de Caralt TM, Perea RJ, Vatasescu R, Brugada J. Left atrial posterior wall isolation does not improve the outcome of circumferential pulmonary vein ablation for atrial fibrillation: a prospective randomized study. Circ Arrhythm Electrophysiol. 2009 Feb;2(1):35-40. doi: 10.1161/CIRCEP.108.797944. Epub 2008 Dec 3.

    PMID: 19808442BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mazda Biria, MD

    Physician of Cardiology and Electrophysiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Trisha D England, MSN

CONTACT

816-271-7937trisha.england2@mymlc.com

Paula S Wilson, MSN

CONTACT

816-271-6718paula.wilson@mymlc.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 27, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)