Clinical trial NCT05366361: The Dynamics of Human Atrial Fibrillation
Official title: The Dynamics of Human Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Arrhythmias, Cardiac
Keywords: ablation
arrhythmias, cardiac
atrial fibrillation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Does the Area of Organized Regions in AF predict success from Ablation?
timeFrame: 1 year.
Secondary outcomes:
measure: Does ablation through larger organized areas explain success from ablation.
timeFrame: 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References: