Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT05366361

Conditions

Atrial Fibrillation

Arrhythmias, Cardiac

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Atrial fibrillation (AF) is an enormous public health problem in the United States, affecting 2-5 million Americans and causing rapid heart beats, stroke, heart failure or death. In this project, the applicant will develop a novel framework to better understand human AF that builds on agreement between several concepts for the disease. The applicant will develop strategies to identify AF patients who will best respond to each of several therapies, to guide personalized therapy.

Conditions

Atrial Fibrillation

Arrhythmias, Cardiac

Study ID

NCT05366361

Start date

Aug 18, 2020

Status verified date

Feb, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • referred for ablation or Maze surgery at Stanford Medicine for persistent AF (i.e. which requires cardioversion to terminate and/or lasts >7 days)
  • Per our clinical practice and guidelines (Calkins et al., Heart Rhythm 2018), patients will have failed or be intolerant of >or= 1 anti-arrhythmic drug. Patients after Maze surgery typically have failed prior endocardial ablation.

Exclusion Criteria:

  • 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
  • prior chest surgery is a relative contraindication for Maze surgery

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients Undergoing Clinically-Indicated Maze Surgery

This group includes patients with persistent AF who will be undergoing clinically-indicated Maze surgery.

Patients Undergoing Clinically-Indicated Ablation

This groups includes patients with persistent AF who will be undergoing clinically-indicated ablation.

Primary outcome measure

  • Does the Area of Organized Regions in AF predict success from Ablation? [ Time Frame: 1 year. ]

Central Contacts and Locations

Central contacts

Anson Lee, MD

(650) 724-7500ansonlee@stanford.edu

Kathleen Mills, BA

kmills2@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Sanjiv Narayan, MD

(650) 724-1850sanjiv1@stanford.edu

Kathleen Mills, BA

kmills2@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • ablation
  • arrhythmias, cardiac
  • atrial fibrillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-02-17.