AzTrials
AzTrials

Atrial FibrillationSAD-POAFNCT07388108

Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery.

An observational study of Atrial Fibrillation and Postoperative Complications, run by School of Medicine. National University of Cuyo at 1 site in Argentina.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to improve the prediction for developing arrhythmias in the postoperative period of cardiovascular surgery by using non-invasive echocardiographic techniques that are sensitive to detect inter and intra-atrial dyssynchrony. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Atrial dyssynchrony
How many people
138 participants
Where
1 siteArgentina
Study dates
6 Feb 2026to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with a history of coronary artery disease, aortic stenosis or a combination of both pathologies, with indication for cardiovascular surgery according to the Guidelines for Cardiovascular Surgery of the European Society of Cardiology.

Who may be able to join

  • Patients with criteria for non-mitral cardiovascular surgery, in sinus rhythm, and who gave informed consent to participate in the study.
  • Absence of atrial fibrillation upon hospital admission for surgery.

Who cannot join

  • Surgery of the mitral or tricuspid valve.
  • History of previous atrial fibrillation.
  • History of congenital heart disease or cardiac tumors.
  • Emergency surgery of the heart
  • Pour echocardiographic window

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Argentina1 site, 1 recruiting
  • Clínica de Cuyo

    Mendoza, Mendozz, 5500

    Francisco Sanchez, PhD, 542614059000 ext. 1250, fsanchez@fcm.uncu.edu.ar

    Ariel Baigorria, Medical degree, +5492614059000 ext. 1142, ariel.baigorria@clinicadecuyo.com.ar

    Recruiting

Other trials in Argentina

About this study

Official title: Atrial Electromechanical Alteration as a Predictor of Arrhythmias in the Postoperative Period After Cardiovascular Surgery

This study aims to improve the prediction for developing arrhythmias in the postoperative period of cardiovascular surgery by using non-invasive echocardiographic techniques that are sensitive to detect inter and intra-atrial dyssynchrony. The main question it aims to answer is:

Do patients with atrial dyssynchrony are at increased risk of developing arrhythmias in the postoperative period of cardiovascular surgery?

Patients admitted to the protocol will undergo an echocardiogram with atrial strain before surgery to determine the presence or absence of intra- and inter-atrial dyssynchrony and will be followed during hospitalization to assess the occurrence of atrial fibrillation in the postoperative period.

Read the detailed description

The overall objective is to improve the prediction of the risk of developing arrhythmias in the postoperative period with non-invasive techniques that are sensitive to detect inter- and intra-atrial dysrhythmias.

Specific objectives

  1. To describe the alterations in left and right atrial deformation by strain method to identify intra- and inter-atrial activation dyssynchrony.
  2. To determine that dyssynchrony predicts a higher incidence of atrial fibrillation in the postoperative period after cardiovascular surgery.
  3. To evaluate whether novel atrial function analysis techniques, such as left atrial ejection fraction assessed via 3D echocardiography, are associated with a higher incidence of postoperative atrial fibrillation.

All patients will undergo a full Doppler echocardiogram with two-dimensional atrial Strain determination with speckle tracking, using an Philips EPIC CVx series echocardiogram machine with S5-1 and X5-1 probes. The images will be obtained in left lateral decubitus. In forced expiration, 3 consecutive beats will be recorded and digitally saved for later analysis in the 4 and 2 chamber views. Both atria must be visualized so that neither atrial wall are lost in the evaluation. Echocardiographic measurements will focus primarily on the indexed left atrial volume obtained by averaging the values obtained in 2 and 4 chambers by the multiple disc method. In these views, the left ventricular ejection fraction will be obtained by the Simpson biplane method. The left atrium will be further subdivided into basal, medial and atrial roof segments, resulting in a total of 12 segments, 6 of which can be observed in the four-chamber view and 6 in the two-chamber view. The right atrium will be divided similarly but will contribute a mere three additional segments to the total (for a total of 15 segments), as the right septal segments were previously regarded as part of the left atrium. The time to maximum deflection, defined as the interval between the onset of the P wave on the electrocardiogram and the maximum deflection of the atrial contraction determined by strain rate, will be measured for each of the 15 atrial segments previously described. To determine interatrial synchrony, an adaptation of the atrial strain will be made so that both atria can be evaluated simultaneously. This new evaluation, which we have designated "OMEGA" (ω) due to its resemblance to the shape of the strain image, will yield the time to maximum deformation of the lateral segments of the right atrium and the lateral segments of the left atrium. Consequently, the difference in activation timing between the lateral segments of the right and left atria will determine the presence of an activation delta between the walls.

A comprehensive analysis of atrial deformation using left and right atrial strain will also be performed. Subsequently, the time-to-peak deformation will be measured from the onset of the P-wave to the peak negative atrial strain deflection, which correlates with atrial contractile strain. Activation time differences derived from this methodology will also be measured to provide an additional assessment of the interatrial activation delay (delta).

Patients will be followed during hospitalization with continuous electrocardiographic monitoring for the first 5 days after surgery to detect the incidence of atrial fibrillation. Patients will undergo telephonic follow-up at 28 and 365 days post-intervention, utilizing a targeted interview to evaluate for the onset of supraventricular arrhythmias.

Study data will be collected and managed using REDCap electronic data capture tools hosted at Faculty of Medicine, National University of Cuyo to a protocol designed specifically for this study.

The sample size calculation is performed according to Schoenfeld's method for Cox models. To detect a hazard ratio of 2.5 for atrial fibrillation events based on the presence or absence of interatrial dyssynchrony-estimating a cumulative event rate of 0.38 in the dyssynchronous group and 0.18 in the synchronous group, with a 0.44 proportion of dyssynchronous patients-and assuming a two-sided alpha level of 0.05 and 80% power, a total sample of 138 patients is determined.

Statistical analysis results are reported as mean (SD), median (p25-p75) or frequency (%). Comparisons between groups were performed with the Student t test or chi-squared analysis. The association between clinical variables and the study end-points was evaluated using survival analysis methodology (Cox regression models). The Kaplan-Meier method was used to estimate the cumulative probability of PAF detection and stroke recurrence in both groups, and comparisons were made by the log-rank test. Significance was set at P < 0.05.

Being tested
Atrial dyssynchrony
Keywords
Atrial fibrillation, Atrial strain, Cardiovascular surgery, Echocardiography
Medical subject headings
Atrial Fibrillation, Postoperative Complications

What participants receive

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

  • Atrial dyssynchronyDiagnostic test

    To determine interatrial dyssynchrony, an adaptation of the echocardiographic atrial strain will be made so that both atria can be evaluated simultaneously. This new evaluation, OMEGA (ω) will yield the time to maximum deformation of the lateral segments of the right atrium and the lateral segments of the left atrium.

    Additionally, total atrial deformation will be evaluated via bi-atrial strain analysis. We will then measure the maximum deformation time-from P-wave onset to the maximum negative strain deflection-to assess its relationship with atrial contraction strain.

What is being measured

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

  1. Incidence of postoperatory atrial fibrillation

    Arrhythmic episodes of at least 30 seconds duration will be considered postoperative atrial fibrillation when detected on continuous monitoring or when detected on a ward ECG, if the patient reported symptoms or required medical intervention.

    Measured: From the end of surgery through hospital discharge, an average of 6 days.

Secondary outcomes (1)
  1. Atrial Fibrillation at 28 and 365 Days

    Telephone follow-ups will be conducted with all patients at 28 and 365 days post-surgery. A brief interview will be administered to screen for the occurrence of arrhythmias during this period. Patients reporting a positive history will be scheduled for an on-site visit to request diagnostic tests documenting the arrhythmia.

    Measured: From surgery through Day 28 and Day 365

Timeline

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

  1. First posted4 Feb 2026
  2. Study start6 Feb 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07388108
Sponsor's protocol ID
003. 03/10/2023.
Acronym
SAD-POAF
Status last verified
Jan 2026
First submitted
19 Jan 2026
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data dictionary of analyzed variables and the corresponding statistical analysis will be available upon formal request by email.

Publications

  • Sanchez FJ, Gonzalez VA, Farrando M, Baigorria Jayat AO, Segovia-Roldan M, Garcia-Mendivil L, Ordovas L, Prado NJ, Pueyo E, Diez ER. Atrial Dyssynchrony Measured by Strain Echocardiography as a Marker of Proarrhythmic Remodeling and Oxidative Stress in Cardiac Surgery Patients. Oxid Med Cell Longev. 2020 Dec 30;2020:8895078. doi: 10.1155/2020/8895078. eCollection 2020.

    PubMed 33456678
  • Badano LP, Kolias TJ, Muraru D, Abraham TP, Aurigemma G, Edvardsen T, D'Hooge J, Donal E, Fraser AG, Marwick T, Mertens L, Popescu BA, Sengupta PP, Lancellotti P, Thomas JD, Voigt JU; Industry representatives; Reviewers: This document was reviewed by members of the 2016-2018 EACVI Scientific Documents Committee. Standardization of left atrial, right ventricular, and right atrial deformation imaging using two-dimensional speckle tracking echocardiography: a consensus document of the EACVI/ASE/Industry Task Force to standardize deformation imaging. Eur Heart J Cardiovasc Imaging. 2018 Jun 1;19(6):591-600. doi: 10.1093/ehjci/jey042.

    PubMed 29596561
  • Aksu U, Kalkan K, Gulcu O, Aksakal E, Ozturk M, Topcu S. The role of the right atrium in development of postoperative atrial fibrillation: A speckle tracking echocardiography study. J Clin Ultrasound. 2019 Oct;47(8):470-476. doi: 10.1002/jcu.22736. Epub 2019 May 17.

    PubMed 31099024
  • Muller P, Hars C, Schiedat F, Bosche LI, Gotzmann M, Strauch J, Dietrich JW, Vogt M, Tannapfel A, Deneke T, Mugge A, Ewers A. Correlation between total atrial conduction time estimated via tissue Doppler imaging (PA-TDI Interval), structural atrial remodeling and new-onset of atrial fibrillation after cardiac surgery. J Cardiovasc Electrophysiol. 2013 Jun;24(6):626-31. doi: 10.1111/jce.12084. Epub 2013 Feb 11.

    PubMed 23398627
  • Merckx KL, De Vos CB, Palmans A, Habets J, Cheriex EC, Crijns HJ, Tieleman RG. Atrial activation time determined by transthoracic Doppler tissue imaging can be used as an estimate of the total duration of atrial electrical activation. J Am Soc Echocardiogr. 2005 Sep;18(9):940-4. doi: 10.1016/j.echo.2005.03.022.

    PubMed 16153518
  • Xu C, Chen K, Yu F, Wang Q, Su H, Yang D, Xu J, Yan J. Atrial Dyssynchrony: A New Predictor for Atrial High-Rate Episodes in Patients with Cardiac Resynchronization Therapy. Cardiology. 2019;144(1-2):18-26. doi: 10.1159/000502541. Epub 2019 Sep 2.

    PubMed 31476753
  • Ciuffo L, Tao S, Gucuk Ipek E, Zghaib T, Balouch M, Lima JAC, Nazarian S, Spragg DD, Marine JE, Berger RD, Calkins H, Ashikaga H. Intra-Atrial Dyssynchrony During Sinus Rhythm Predicts Recurrence After the First Catheter Ablation for Atrial Fibrillation. JACC Cardiovasc Imaging. 2019 Feb;12(2):310-319. doi: 10.1016/j.jcmg.2017.11.028. Epub 2018 Jan 17.

    PubMed 29361492
  • Pathan F, D'Elia N, Nolan MT, Marwick TH, Negishi K. Normal Ranges of Left Atrial Strain by Speckle-Tracking Echocardiography: A Systematic Review and Meta-Analysis. J Am Soc Echocardiogr. 2017 Jan;30(1):59-70.e8. doi: 10.1016/j.echo.2016.09.007. Epub 2016 Oct 27.

    PubMed 28341032
  • Swartz MF, Fink GW, Sarwar MF, Hicks GL, Yu Y, Hu R, Lutz CJ, Taffet SM, Jalife J. Elevated pre-operative serum peptides for collagen I and III synthesis result in post-surgical atrial fibrillation. J Am Coll Cardiol. 2012 Oct 30;60(18):1799-806. doi: 10.1016/j.jacc.2012.06.048.

    PubMed 23040566
  • Lacalzada-Almeida J, Izquierdo-Gomez MM, Belleyo-Belkasem C, Barrio-Martinez P, Garcia-Niebla J, Elosua R, Jimenez-Sosa A, Escobar-Robledo LA, Bayes de Luna A. Interatrial block and atrial remodeling assessed using speckle tracking echocardiography. BMC Cardiovasc Disord. 2018 Feb 21;18(1):38. doi: 10.1186/s12872-018-0776-6.

    PubMed 29466939
  • Hatam N, Aljalloud A, Mischke K, Karfis EA, Autschbach R, Hoffmann R, Goetzenich A. Interatrial conduction disturbance in postoperative atrial fibrillation: a comparative study of P-wave dispersion and Doppler myocardial imaging in cardiac surgery. J Cardiothorac Surg. 2014 Jun 24;9:114. doi: 10.1186/1749-8090-9-114.

    PubMed 24957051
  • Osranek M, Fatema K, Qaddoura F, Al-Saileek A, Barnes ME, Bailey KR, Gersh BJ, Tsang TS, Zehr KJ, Seward JB. Left atrial volume predicts the risk of atrial fibrillation after cardiac surgery: a prospective study. J Am Coll Cardiol. 2006 Aug 15;48(4):779-86. doi: 10.1016/j.jacc.2006.03.054. Epub 2006 Jul 25.

    PubMed 16904549
  • Liberale L, Montecucco F, Tardif JC, Libby P, Camici GG. Inflamm-ageing: the role of inflammation in age-dependent cardiovascular disease. Eur Heart J. 2020 Aug 14;41(31):2974-2982. doi: 10.1093/eurheartj/ehz961.

    PubMed 32006431
  • Zakkar M, Ascione R, James AF, Angelini GD, Suleiman MS. Inflammation, oxidative stress and postoperative atrial fibrillation in cardiac surgery. Pharmacol Ther. 2015 Oct;154:13-20. doi: 10.1016/j.pharmthera.2015.06.009. Epub 2015 Jun 24.

    PubMed 26116810
  • Maesen B, Nijs J, Maessen J, Allessie M, Schotten U. Post-operative atrial fibrillation: a maze of mechanisms. Europace. 2012 Feb;14(2):159-74. doi: 10.1093/europace/eur208. Epub 2011 Aug 6.

    PubMed 21821851

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Postoperative Complications, run by School of Medicine. National University of Cuyo at 1 site in Argentina.

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 5 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. 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 Argentina. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Francisco Sánchez, PhD (+5492614135000 ext. 2659, fsanchez@fcm.uncu.edu.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postoperatory atrial fibrillation (time frame: From the end of surgery through hospital discharge, an average of 6 days.). 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 NCT07388108, which also lists 18 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 10 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in