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NCT Number: NCT05366361

The Dynamics of Human Atrial Fibrillation

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.

Recruiting

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Key information

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The specific aim of this clinical study is to identify patients who will or will not respond to PVI, PVI plus other ablation or Maze surgery based on locations of organized-to-disorganized areas and clinical profile. We will develop non-invasive ECGI and intracardiac recordings in our registry, then test them prospectively in an observational study.

Premise: Identifying responders or non-responders to PVI alone, or PVI plus other ablation or Maze surgery may enable patient-tailored therapy. This may raise overall success, reduce risks from unsuccessful procedures and improve resource utilization(58,128-130). This proposal will prospectively test in single-arm observations studies if patients who exhibit large organized AF areas at planned ablation regions have higher procedural success than patients with smaller areas. We will use non-invasive ECGI indices of organized AF, based on Preliminary data(9, 84, 85).

This project is significant because it will establish a deeper understanding of AF and will develop strategies to identify AF patients who will best respond to each of several therapies, to guide personalized therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 1 year.

    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.

Secondary outcomes

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

    Time frame: 1 year

    We will map areas of organized activity in all patients. We will compare if patients with ablation lesions through organized areas, or that eliminates organized areas, have higher or lower success from ablation (determined by absence of recurrent AF or atrial tachycardia on outpatient monitoring) than patients in whom ablation did not encroach on organized areas.

Study contacts

Contact information is provided by the study sponsor or research team.

Anson Lee, MD

CONTACT

[email protected]

(650) 724-7500

Kathleen Mills, BA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
May 9, 2022
Registry last updated
Feb 17, 2026

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.

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