The Dynamics of Human Atrial Fibrillation

  • STATUS
    Recruiting
  • End date
    Dec 30, 2026
  • participants needed
    200
  • sponsor
    Stanford University
Updated on 28 May 2022
stroke
heart failure
fibrillation
antiarrhythmic drug
cardioversion

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.

Description

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.

Details
Condition Atrial Fibrillation, Arrhythmias, Cardiac
Clinical Study IdentifierNCT05366361
SponsorStanford University
Last Modified on28 May 2022

Eligibility

Yes No Not Sure

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
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