Non - Invasive Evaluation of the Left Atrium Anatomy and Function

Atrial Fibrillation Clinical Trial

Official title:

The Search for Non-invasive Determinants of Response to Ablation of Atrial Fibrillation. Non-invasive Evaluation of Left Atrium Anatomy and Function With Three Dimensional Echocardiography: Comparison With Cardiac CT and MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551158
• Other study ID #: 2017/221
• Status: Completed
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: December 28, 2019

Study information

• Verified date: August 2017
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study implies three parts. The first part of the study aims to evaluate the variability and reproducibility of rest two - and three-dimensional echocardiography for the left atrium anatomy and function and to assess their correlation with clinical variables.

The second part of the study aims to evaluate the accuracy and reproducibility of the left atrium anatomy and function using echocardiography and to validate it with cardiac CT. Moreover, the study aims to evaluate which parameters can predict the recurrence of atrial fibrillation in patients who have undergone atrial fibrillation ablation.

The third part of the study aims to assess the accuracy and variability of echocardiographic measurements compared to cardiac magnetic resonance and to find predictors of recurrence after cryoballoon ablation for atrial fibrillation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 28, 2019
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• older than 18 years old

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• Echocardiography
Cardiac imaging for the assessment of the left atrium anatomy and function.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (11)

Agner BF, Kühl JT, Linde JJ, Kofoed KF, Åkeson 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. — View Citation

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). pii: e004229. doi: 10.1161/CIRCIMAGING.115.004229. — View Citation

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. — View Citation

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. — View Citation

Gerede DM, Candemir B, Vurgun VK, Aghdam SM, Acibuca A, Özcan ÖU, Göksülük H, Kervancioglu C, Erol Ç. Prediction of recurrence after cryoballoon ablation therapy in patients with paroxysmal atrial fibrillation. Anatol J Cardiol. 2015 Sep 15. doi: 10.5152/AnatolJCardiol.2015.6309. [Epub ahead of print] — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. Erratum in: Eur Heart J Cardiovasc Imaging. 2016 Apr;17(4):412. Eur Heart J Cardiovasc Imaging. 2016 Sep;17 (9):969. — View Citation

Mor-Avi V, Yodwut C, Jenkins C, Kühl 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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation recurrence	Predictors of atrial fibrillation recurrence after ablation	1 year