Stanford University
Stanford, California, 94305, United States
Location status: Recruiting
Location contact
Kathleen Mills, BA
CONTACT
Sanjiv Narayan, MD
CONTACT
NCT Number: NCT05371405
Atrial fibrillation is a serious public health issue that affects over 5 million Americans (Miyazaka, Circulation 2006) in whom it may cause skipped beats, dizziness, stroke and even death. Therapy for AF is currently suboptimal, in part because AF represents several disease states of which few have been delineated or used to successfully guide management. This study seeks to clarify this delineation of AF types using machine learning (ML).
Interested in participating?
Request Info22 year–80 year
All sexes
Observational
Stanford, California, 94305, United States
Location status: Recruiting
Kathleen Mills, BA
CONTACT
Sanjiv Narayan, MD
CONTACT
This project tests the novel hypothesis that "Machine learning (ML) in AF patients can integrate physiological data across biological scales stratified by labeled outcomes, and use explainability analyses to identify electrical, structural and clinical determinants of ablation outcome in individual patients to guide personalized therapy". We address this hypothesis using a combined computational/clinical approach. The project will recruit 120 patients to address 3 Specific Aims.
Aim 1. To identify components of AF electrograms that indicate depolarization, repolarization or other mechanisms at the tissue level, using ML trained to monophasic action potentials (MAP). For this prospective protocol, we will collect electrograms using a MAP catheter at multiple atrial sites in patients undergoing AF ablation. We will then test if our algorithms developed previously from our registry, can predict MAP timings from AF electrograms.
Aim 2. To identify electrical and structural features of the acute response of AF to ablation near and remote from PVs at the individual heart level using machine learning and biostatistical approaches. For this prospective protocol, we will recruit patients undergoing their standard-of-care ablation and test if an ML classifier developed previously in a registry dataset prospectively predicts acute response to specific ablation strategies.
Aim 3. To identify patients in whom ablation is unsuccessful or successful long-term using ML and biostatistics. For this prospective protocol, we will recruit patients undergoing their standard-of-care ablation and test if an ML classifier developed previously in a registry dataset prospectively predicts 1 year freedom from atrial arrhythmias.
This project is significant because it will establish a deeper understanding of AF and might reveal novel mechanisms of AF maintenance. Our results can be translated directly to practice and may enable the development of better treatment options.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 year.
To compare success of AF ablation in each patient at 1 year (defined as absence of AF or atrial tachycardia on outpatient monitoring) to predicted success by the machine learning algorithm developed in this project. The outcome compares observed success at 1 year (Yes, No) to (a) a binary predictor and (b) a continuous variable of success from the algorithm. The machine learning algorithm is trained on clinical and electrophysiological data to predict if certain lesion sets will or will not be successful.
Time frame: 1 year
To determine if AF ablation success at 1 year (defined as absence of AF or atrial tachycardia on outpatient monitoring) correlates with the ablation of regions predicted by the machine learning algorithm in this project to be successful ablation targets.
Contact information is provided by the study sponsor or research team.
Kathleen Mills, BA
CONTACT
Sanjiv Narayan, MD
CONTACT
Stanford University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07621055
Arrhythmias, Cardiac, Atrial Arrhythmia
Marseille, France
View Trial DetailsNCT05452356
Arrhythmias, Cardiac, Atrial Fibrillation
London, Ontario, Canada
View Trial DetailsNCT06938412
Arrhythmias, Cardiac, Atrial Fibrillation
New York, United States
View Trial DetailsNCT06358391
Arrhythmias, Cardiac, Atrial Fibrillation
Bucheon-si, South Korea
View Trial Details