The Dynamics of Human Atrial Fibrillation

NCT05366361 | Recruiting

• 1 other identifier: 57424
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Arrhythmias, Cardiac; Atrial Fibrillation

Keywords

ablation; arrhythmias, cardiac; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Does the Area of Organized Regions in AF predict success from Ablation?

  We will map areas of organized activity in all patients. We will compare if patients with success from ablation (absence of recurrent AF or atrial tachycardia on outpatient monitoring) have larger organized areas than those without success.

  1 year.

Secondary Outcomes (1)

• Does ablation through larger organized areas explain success from ablation.

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include men and women of any ethnicity aged \>21 years 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.

You may qualify if:

• 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.

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
• prior chest surgery is a relative contraindication for Maze surgery

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Anson Lee, MD

CONTACT

(650) 724-7500; ansonlee@stanford.edu

Kathleen Mills, BA

CONTACT

kmills2@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiothoracic Surgery

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 9, 2022
• Study Start: August 18, 2020
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)