Understanding Atrial Fibrillation Dynamics
The Dynamics of Human Atrial Fibrillation
This study is trying to find out how different treatments for atrial fibrillation work for individual patients to improve their chances of success and lower risks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 22 Years to 80 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05366361 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a framework for understanding atrial fibrillation (AF) by identifying patients who will respond to various therapies, including pulmonary vein isolation (PVI) and Maze surgery. The study will utilize non-invasive electrocardiographic imaging (ECGI) and intracardiac recordings to assess the relationship between organized and disorganized AF areas and patient outcomes. By focusing on personalized therapy, the study seeks to improve procedural success rates and reduce risks associated with unsuccessful treatments.
Who should consider this trial
Good fit: Ideal candidates are patients referred for ablation or Maze surgery at Stanford Medicine for persistent atrial fibrillation who have failed or are intolerant to at least one anti-arrhythmic drug.
Not a fit: Patients with active coronary ischemia, decompensated heart failure, or other specified exclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, personalized treatment strategies for patients with atrial fibrillation.
How similar studies have performed: Other studies have shown promise in using personalized approaches to treat atrial fibrillation, but this specific framework is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Study coordinator: Anson Lee, MD
- Email: ansonlee@stanford.edu
- Phone: (650) 724-7500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.