COMparison of Physiological Algorithms for Real-time Evaluation of Atrial Fibrillation

NCT02997254 | Recruiting

• 1 other identifier: COMPARE_AF
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cohort study to evaluate algorithms for mapping atrial fibrillation by mapping atrial structure and mapping electrical activity to detect physiologically important areas. A key innovation of the observation study is to assess tracking of physiological activity in AF, in relation to tissue activity (MAP recordings), and in relation to AF waves of activity. This observational work extends prior studies that focused on focal and rotational activity, dispersion of electrical activity, low voltage activity and others.

Conditions

Atrial Fibrillation; Abnormal Heart Rhythms

Keywords

atrial fibrillation; ablation; abnormal heart rhythm

Outcome Measures

Primary Outcomes (2)

• Diagnostic Accuracy

  Comparing electrogram analysis systems to diagnose sites of importance in Atrial Fibrillation

  At the time of procedure

• Diagnostic Accuracy

  Comparing algorithms to segment atrial structures from computed tomography or Magnetic resonance images.

  At time of procedure.

Secondary Outcomes (1)

• Analysis Time

  At time of procedure.

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will study adults aged 21-90 years who have undergone electrophysiology study for ablation of Atrial Fibrillation. De-identified datasets will be made available for comparisons of mapping approaches.

You may qualify if:

• aged 21-80 yrs who underwent electrophysiology study for ablation of Atrial Fibrillation

You may not qualify if:

• Poor data quality of recordings of AF

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Related Publications (21)

• Alhusseini M, Vidmar D, Meckler GL, Kowalewski CA, Shenasa F, Wang PJ, Narayan SM, Rappel WJ. Two Independent Mapping Techniques Identify Rotational Activity Patterns at Sites of Local Termination During Persistent Atrial Fibrillation. J Cardiovasc Electrophysiol. 2017 Jun;28(6):615-622. doi: 10.1111/jce.13177. Epub 2017 Mar 20.

  PMID: 28185348 BACKGROUND

• Alhusseini MI, Abuzaid F, Rogers AJ, Zaman JAB, Baykaner T, Clopton P, Bailis P, Zaharia M, Wang PJ, Rappel WJ, Narayan SM. Machine Learning to Classify Intracardiac Electrical Patterns During Atrial Fibrillation: Machine Learning of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2020 Aug;13(8):e008160. doi: 10.1161/CIRCEP.119.008160. Epub 2020 Jul 6.

  PMID: 32631100 BACKGROUND

• Tang S, Razeghi O, Kapoor R, Alhusseini MI, Fazal M, Rogers AJ, Rodrigo Bort M, Clopton P, Wang PJ, Rubin DL, Narayan SM, Baykaner T. Machine Learning-Enabled Multimodal Fusion of Intra-Atrial and Body Surface Signals in Prediction of Atrial Fibrillation Ablation Outcomes. Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e010850. doi: 10.1161/CIRCEP.122.010850. Epub 2022 Jul 22.

  PMID: 35867397 BACKGROUND

• Svennberg E, Han JK, Caiani EG, Engelhardt S, Ernst S, Friedman P, Garcia R, Ghanbari H, Hindricks G, Man SH, Millet J, Narayan SM, Ng GA, Noseworthy PA, Tjong FVY, Ramirez J, Singh JP, Trayanova N, Duncker D, Tfelt Hansen J, Barker J, Casado-Arroyo R, Chatterjee NA, Conte G, Diederichsen SZ, Linz D, Mahtani AU, Zorzi A. State of the Art of Artificial Intelligence in Clinical Electrophysiology in 2025: A Scientific Statement of the European Heart Rhythm Association (EHRA) of the ESC, the Heart Rhythm Society (HRS), and the ESC Working Group on E-Cardiology. Europace. 2025 May 7;27(5):euaf071. doi: 10.1093/europace/euaf071.

  PMID: 40163651 BACKGROUND

• Armoundas AA, Narayan SM, Arnett DK, Spector-Bagdady K, Bennett DA, Celi LA, Friedman PA, Gollob MH, Hall JL, Kwitek AE, Lett E, Menon BK, Sheehan KA, Al-Zaiti SS; American Heart Association Institute for Precision Cardiovascular Medicine; Council on Cardiovascular and Stroke Nursing; Council on Lifelong Congenital Heart Disease and Heart Health in the Young; Council on Cardiovascular Radiology and Intervention; Council on Hypertension; Council on the Kidney in Cardiovascular Disease; and Stroke Council. Use of Artificial Intelligence in Improving Outcomes in Heart Disease: A Scientific Statement From the American Heart Association. Circulation. 2024 Apr 2;149(14):e1028-e1050. doi: 10.1161/CIR.0000000000001201. Epub 2024 Feb 28.

  PMID: 38415358 BACKGROUND

• Narayan SM, Wan EY, Andrade JG, Avari Silva JN, Bhatia NK, Deneke T, Deshmukh AJ, Chon KH, Erickson L, Ghanbari H, Noseworthy PA, Pathak RK, Roelle L, Seiler A, Singh JP, Srivatsa UN, Trela A, Tsiperfal A, Varma N, Yousuf OK. Visions for digital integrated cardiovascular care: HRS Digital Health Committee perspectives. Cardiovasc Digit Health J. 2024 Feb 24;5(2):37-49. doi: 10.1016/j.cvdhj.2024.02.003. eCollection 2024 Apr. No abstract available.

  PMID: 38765620 BACKGROUND

• Armoundas AA, Ahmad FS, Bennett DA, Chung MK, Davis LL, Dunn J, Narayan SM, Slotwiner DJ, Wiley KK Jr, Khera R; American Heart Association Data Science and Precision Medicine Committee of the Council on Genomic and Precision Medicine and Council on Clinical Cardiology; Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Peripheral Vascular Disease; Council on Quality of Care and Outcomes Research; and Stroke Council. Data Interoperability for Ambulatory Monitoring of Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circ Genom Precis Med. 2024 Jun;17(3):e000095. doi: 10.1161/HCG.0000000000000095. Epub 2024 May 23.

  PMID: 38779844 BACKGROUND

• de Groot NMS, Kleber A, Narayan SM, Ciaccio EJ, Doessel O, Bernus O, Berenfeld O, Callans D, Fedorov V, Hummel J, Haissaguerre M, Natale A, Trayanova N, Spector P, Vigmond E, Anter E. Atrial fibrillation nomenclature, definitions, and mechanisms: Position paper from the international Working Group of the Signal Summit. Heart Rhythm. 2025 Jun;22(6):1480-1491. doi: 10.1016/j.hrthm.2024.11.012. Epub 2024 Nov 17.

  PMID: 39561931 BACKGROUND

• Goldberger JJ, Mitrani RD, Zaatari G, Narayan SM. Mechanistic Insights From Trials of Atrial Fibrillation Ablation: Charting a Course for the Future. Circ Arrhythm Electrophysiol. 2024 Aug;17(8):e012939. doi: 10.1161/CIRCEP.124.012939. Epub 2024 Jul 23.

  PMID: 39041221 BACKGROUND

• Sillett C, Razeghi O, Baptiste TMG, Lee AWC, Solis Lemus JA, Rodero C, Roney CH, Feng R, Ganesan P, Chang HJ, Clopton P, Linton N, Rajani R, Rogers AJ, Narayan SM, Niederer SA. Identification of atrial myopathy and atrial fibrillation recurrence after ablation using 3D left atrial phasic strain from retrospective gated computed tomography. Eur Heart J Imaging Methods Pract. 2025 Mar 6;3(1):qyaf027. doi: 10.1093/ehjimp/qyaf027. eCollection 2025 Jan.

  PMID: 40171523 BACKGROUND

• Ganesan P, Deb B, Feng R, Rodrigo M, Ruiperez-Campillo S, Rogers AJ, Clopton P, Wang PJ, Zeemering S, Schotten U, Rappel WJ, Narayan SM. Quantifying a spectrum of clinical response in atrial tachyarrhythmias using spatiotemporal synchronization of electrograms. Europace. 2023 May 19;25(5):euad055. doi: 10.1093/europace/euad055.

  PMID: 36932716 BACKGROUND

• Feng R, Deb B, Ganesan P, Tjong FVY, Rogers AJ, Ruiperez-Campillo S, Somani S, Clopton P, Baykaner T, Rodrigo M, Zou J, Haddad F, Zahari M, Narayan SM. Segmenting computed tomograms for cardiac ablation using machine learning leveraged by domain knowledge encoding. Front Cardiovasc Med. 2023 Oct 2;10:1189293. doi: 10.3389/fcvm.2023.1189293. eCollection 2023.

  PMID: 37849936 BACKGROUND

• Ganesan P, Pedron M, Feng R, Rogers AJ, Deb B, Chang HJ, Ruiperez-Campillo S, Srivastava V, Brennan KA, Giles WR, Baykaner T, Clopton P, Wang PJ, Schotten U, Krummen DE, Narayan SM. Comparing Phenotypes for Acute and Long-Term Response to Atrial Fibrillation Ablation Using Machine Learning. Circ Arrhythm Electrophysiol. 2025 Feb;18(2):e012860. doi: 10.1161/CIRCEP.124.012860. Epub 2025 Feb 10.

  PMID: 39925268 BACKGROUND

• Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.

  PMID: 22818076 BACKGROUND

• Narayan SM, Krummen DE, Enyeart MW, Rappel WJ. Computational mapping identifies localized mechanisms for ablation of atrial fibrillation. PLoS One. 2012;7(9):e46034. doi: 10.1371/journal.pone.0046034. Epub 2012 Sep 26.

  PMID: 23049929 BACKGROUND

• Benharash P, Buch E, Frank P, Share M, Tung R, Shivkumar K, Mandapati R. Quantitative analysis of localized sources identified by focal impulse and rotor modulation mapping in atrial fibrillation. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):554-61. doi: 10.1161/CIRCEP.115.002721. Epub 2015 Apr 14.

  PMID: 25873718 BACKGROUND

• Jalife J, Filgueiras Rama D, Berenfeld O. Letter by Jalife et al Regarding Article, "Quantitative Analysis of Localized Sources Identified by Focal Impulse and Rotor Modulation Mapping in Atrial Fibrillation". Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1296-8. doi: 10.1161/CIRCEP.115.003324. No abstract available.

  PMID: 26487627 BACKGROUND

• Kuklik P, Zeemering S, Maesen B, Maessen J, Crijns HJ, Verheule S, Ganesan AN, Schotten U. Reconstruction of instantaneous phase of unipolar atrial contact electrogram using a concept of sinusoidal recomposition and Hilbert transform. IEEE Trans Biomed Eng. 2015 Jan;62(1):296-302. doi: 10.1109/TBME.2014.2350029. Epub 2014 Aug 20.

  PMID: 25148659 BACKGROUND

• Kuklik P, Zeemering S, van Hunnik A, Maesen B, Pison L, Lau DH, Maessen J, Podziemski P, Meyer C, Schaffer B, Crijns H, Willems S, Schotten U. Identification of Rotors during Human Atrial Fibrillation Using Contact Mapping and Phase Singularity Detection: Technical Considerations. IEEE Trans Biomed Eng. 2017 Feb;64(2):310-318. doi: 10.1109/TBME.2016.2554660. Epub 2016 Apr 15.

  PMID: 27101596 BACKGROUND

• Haissaguerre M, Hocini M, Denis A, Shah AJ, Komatsu Y, Yamashita S, Daly M, Amraoui S, Zellerhoff S, Picat MQ, Quotb A, Jesel L, Lim H, Ploux S, Bordachar P, Attuel G, Meillet V, Ritter P, Derval N, Sacher F, Bernus O, Cochet H, Jais P, Dubois R. Driver domains in persistent atrial fibrillation. Circulation. 2014 Aug 12;130(7):530-8. doi: 10.1161/CIRCULATIONAHA.113.005421. Epub 2014 Jul 15.

  PMID: 25028391 BACKGROUND

• Kowalewski CAB, Shenasa F, Rodrigo M, Clopton P, Meckler G, Alhusseini MI, Swerdlow MA, Joshi V, Hossainy S, Zaman JAB, Baykaner T, Rogers AJ, Brachmann J, Miller JM, Krummen DE, Sauer WH, Peters NS, Wang PJ, Narayan SM. Interaction of Localized Drivers and Disorganized Activation in Persistent Atrial Fibrillation: Reconciling Putative Mechanisms Using Multiple Mapping Techniques. Circ Arrhythm Electrophysiol. 2018 Jun;11(6):e005846. doi: 10.1161/CIRCEP.117.005846.

  PMID: 29884620 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sanjiv M Narayan, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjiv M Narayan, MD, PhD

CONTACT

(650) 723-9363; sanjiv1@stanford.edu

Kathleen C Mills, BA

CONTACT

(650) 723-9363; kmills2@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Principal Investigator

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 20, 2016
• Study Start: December 1, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)