NCT05371405

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Feb 2020Dec 2027

Study Start

First participant enrolled

February 12, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

6.8 years

First QC Date

April 22, 2022

Last Update Submit

November 12, 2025

Conditions

Keywords

machine learningablationatrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • Machine Learning Prediction of Ablation Outcome

    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.

    1 year.

Secondary Outcomes (1)

  • Machine Learning to Identify Ablation targets

    1 year

Eligibility Criteria

Age22 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be men and women of any ethnicity aged 22-80 years undergoing ablation at Stanford of (a) paroxysmal AF (self-terminates \< 7 days), or (b) persistent AF (requires cardioversion to terminate). Per our clinical practice and guidelines (Calkins et al, Heart Rhythm 2012), patients will have failed or be intolerant of ≥ 1 anti-arrhythmic drug.

You may qualify if:

  • undergoing ablation at Stanford of (a) paroxysmal AF (self-terminates \< 7 days), or (b) persistent AF (requires cardioversion to terminate).
  • Per our clinical practice and guidelines (Calkins et al, Heart Rhythm 2012), patients will have failed or be intolerant of ≥ 1 anti-arrhythmic drug.

You may not qualify if:

  • active coronary ischemia or decompensated heart failure
  • atrial or ventricular clot on trans-esophageal echocardiography
  • pregnancy (to minimize fluoroscopic exposure)
  • inability or unwillingness to provide informed consent
  • rheumatic valve disease (results in a unique AF phenotype)
  • thrombotic disease or venous filters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Sanjiv Narayan, MD

CONTACT

Kathleen Mills, BA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 22, 2022

First Posted

May 12, 2022

Study Start

February 12, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

November 14, 2025

Record last verified: 2025-11

Locations