The Dynamics of Human Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22-80
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Patients Undergoing Clinically-Indicated Maze Surgery
Group B: Patients Undergoing Clinically-Indicated Ablation
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year.Secondary outcomes
1
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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov