The Dynamics of Human Atrial Fibrillation

Stanford University

Status: Enrolling

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac

Study type: Observational

Funder types: Other

Identifiers

NCT05366361

57424

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Patients Undergoing Clinically-Indicated Maze Surgery

Description:

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

Patients Undergoing Clinically-Indicated Ablation

Description:

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