NCT03551158

Brief Summary

The aim of the study is to evaluate the accuracy and reproducibility of the left atrium (LA) anatomy and function in different populations and in patients with atrial fibrillation who have undergone cryoballoon ablation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 28, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2019

Completed
Last Updated

March 25, 2020

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

February 27, 2018

Last Update Submit

March 24, 2020

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation recurrence

    Predictors of atrial fibrillation recurrence after ablation

    1 year

Study Arms (1)

Atrial fibrillation patients

OTHER

Patients with atrial fibrillation who underwent cryoballoon ablation

Diagnostic Test: Echocardiography

Interventions

EchocardiographyDIAGNOSTIC_TEST

Cardiac imaging for the assessment of the left atrium anatomy and function.

Also known as: cardiac computed tomography, cardiac magnetic resonance
Atrial fibrillation patients

Eligibility Criteria

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

You may qualify if:

  • subsequent group of patients sent to the echocardiography laboratory for any indication/patients who have undergone a cryoballoon ablation
  • older than 18 years old

You may not qualify if:

  • inadequate image quality during echocardiography, contraindications for computed tomography or cardiac magnetic resonance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Related Publications (11)

  • Hoit BD. Left atrial size and function: role in prognosis. J Am Coll Cardiol. 2014 Feb 18;63(6):493-505. doi: 10.1016/j.jacc.2013.10.055. Epub 2013 Nov 27.

    PMID: 24291276BACKGROUND

  • Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.

    PMID: 27567408BACKGROUND

  • Garg J, Chaudhary R, Palaniswamy C, Shah N, Krishnamoorthy P, Bozorgnia B, Natale A. Cryoballoon versus Radiofrequency Ablation for Atrial Fibrillation: A Meta-analysis of 16 Clinical Trials. J Atr Fibrillation. 2016 Oct 31;9(3):1429. doi: 10.4022/jafib.1429. eCollection 2016 Oct-Nov.

    PMID: 28496925BACKGROUND

  • Gerede DM, Candemir B, Vurgun VK, Aghdam SM, Acibuca A, Ozcan OU, Goksuluk H, Kervancioglu C, Erol C. Prediction of recurrence after cryoballoon ablation therapy in patients with paroxysmal atrial fibrillation. Anatol J Cardiol. 2015 Sep 15;16(7):482-8. doi: 10.5152/AnatolJCardiol.2015.6309. Online ahead of print.

    PMID: 26680545BACKGROUND

  • Badano LP, Pezzutto N, Marinigh R, Cinello M, Nucifora G, Pavoni D, Gianfagna P, Fioretti PM. How many patients would be misclassified using M-mode and two-dimensional estimates of left atrial size instead of left atrial volume? A three-dimensional echocardiographic study. J Cardiovasc Med (Hagerstown). 2008 May;9(5):476-84. doi: 10.2459/JCM.0b013e3282f194f0.

    PMID: 18403999BACKGROUND

  • Nedios S, Kosiuk J, Koutalas E, Kornej J, Sommer P, Arya A, Richter S, Rolf S, Husser D, Hindricks G, Bollmann A. Comparison of left atrial dimensions in CT and echocardiography as predictors of long-term success after catheter ablation of atrial fibrillation. J Interv Card Electrophysiol. 2015 Sep;43(3):237-44. doi: 10.1007/s10840-015-0010-8. Epub 2015 May 9.

    PMID: 25956477BACKGROUND

  • Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014.

    PMID: 25712077BACKGROUND

  • Badano LP, Miglioranza MH, Mihaila S, Peluso D, Xhaxho J, Marra MP, Cucchini U, Soriani N, Iliceto S, Muraru D. Left Atrial Volumes and Function by Three-Dimensional Echocardiography: Reference Values, Accuracy, Reproducibility, and Comparison With Two-Dimensional Echocardiographic Measurements. Circ Cardiovasc Imaging. 2016 Jul;9(7):e004229. doi: 10.1161/CIRCIMAGING.115.004229.

    PMID: 27412658BACKGROUND

  • Mor-Avi V, Yodwut C, Jenkins C, Kuhl H, Nesser HJ, Marwick TH, Franke A, Weinert L, Niel J, Steringer-Mascherbauer R, Freed BH, Sugeng L, Lang RM. Real-time 3D echocardiographic quantification of left atrial volume: multicenter study for validation with CMR. JACC Cardiovasc Imaging. 2012 Aug;5(8):769-77. doi: 10.1016/j.jcmg.2012.05.011.

    PMID: 22897989BACKGROUND

  • Todaro MC, Choudhuri I, Belohlavek M, Jahangir A, Carerj S, Oreto L, Khandheria BK. New echocardiographic techniques for evaluation of left atrial mechanics. Eur Heart J Cardiovasc Imaging. 2012 Dec;13(12):973-84. doi: 10.1093/ehjci/jes174. Epub 2012 Aug 21.

    PMID: 22909795BACKGROUND

  • Agner BF, Kuhl JT, Linde JJ, Kofoed KF, Akeson P, Rasmussen BV, Jensen GB, Dixen U. Assessment of left atrial volume and function in patients with permanent atrial fibrillation: comparison of cardiac magnetic resonance imaging, 320-slice multi-detector computed tomography, and transthoracic echocardiography. Eur Heart J Cardiovasc Imaging. 2014 May;15(5):532-40. doi: 10.1093/ehjci/jet239. Epub 2013 Nov 17.

    PMID: 24247925BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Steven Droogmans, Professor

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

June 11, 2018

Study Start

November 28, 2017

Primary Completion

June 28, 2018

Study Completion

December 28, 2019

Last Updated

March 25, 2020

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)