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Atrial FibrillationNCT03551158

Non - Invasive Evaluation of the Left Atrium Anatomy and Function

A study testing Echocardiography in people with Atrial Fibrillation, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation
What is being tested?
Echocardiography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteBelgium
Study dates
28 Nov 2017to 28 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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

Other trials in Belgium

About this study

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

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.

Read the detailed 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.

Being tested
Echocardiography
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • EchocardiographyDiagnostic test

    Also called cardiac computed tomography, cardiac magnetic resonance

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

Study groups in NCT03551158
Study groupRoleWhat they receive
Atrial fibrillation patientsOtherPatients with atrial fibrillation who underwent cryoballoon ablation
Receives: Diagnostic Test: Echocardiography

What is being measured

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

  1. Atrial fibrillation recurrence

    Predictors of atrial fibrillation recurrence after ablation

    Measured: 1 year

Timeline

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

  1. First posted11 Jun 2018
  2. Study start28 Nov 2017
  3. Primary completion28 Jun 2018
  4. Study completion28 Dec 2019

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03551158
Sponsor's protocol ID
2017/221
Status last verified
Aug 2017
First submitted
27 Feb 2018
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24291276

  • 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.

    PubMed 27567408

  • 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.

    PubMed 28496925

  • 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):482-488. doi: 10.5152/AnatolJCardiol.2015.6309.

    PubMed 26680545

  • 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.

    PubMed 18403999

  • 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.

    PubMed 25956477

  • 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.

    PubMed 25712077

  • 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.

    PubMed 27412658

  • 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.

    PubMed 22897989

  • 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.

    PubMed 22909795

  • 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.

    PubMed 24247925

Questions about this trial

What is this clinical trial studying?

A study testing Echocardiography in people with Atrial Fibrillation, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Atrial fibrillation recurrence (time frame: 1 year). 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 NCT03551158, which also lists 11 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 25 Mar 2020.

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