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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Undergoing Clinically-Indicated Maze Surgery | This group includes patients with persistent AF who will be undergoing clinically-indicated Maze surgery. | ||
| Patients Undergoing Clinically-Indicated Ablation | This groups includes patients with persistent AF who will be undergoing clinically-indicated ablation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Does the Area of Organized Regions in AF predict success from Ablation? | 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. | 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Does ablation through larger organized areas explain success from ablation. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anson Lee, MD | Contact | (650) 724-7500 | ansonlee@stanford.edu | |
| Kathleen Mills, BA | Contact | kmills2@stanford.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1 year |