The Dynamics of Human Atrial Fibrillation

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Kathleen Mills, BA; Email: kmills2@stanford.edu
• Study Contact Backup: Name: Sanjiv Narayan, MD; Phone Number: (650) 724-1850; Email: sanjiv1@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Sanjiv Narayan, MD; Phone Number: 650-724-1850; Email: sanjiv1@stanford.edu
      • Contact: Kathleen Mills, BA; Email: kmills2@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	1 year

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2020
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: atrial fibrillation; ablation; arrhythmias, cardiac
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: 57424

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No