Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2020-08-18
2026-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients Undergoing Clinically-Indicated Maze Surgery
This group includes patients with persistent AF who will be undergoing clinically-indicated Maze surgery.
No interventions assigned to this group
Patients Undergoing Clinically-Indicated Ablation
This groups includes patients with persistent AF who will be undergoing clinically-indicated ablation.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
80 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Sanjiv Narayan, MD, PhD
Professor of Medicine
Locations
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Stanford University
Stanford, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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57424
Identifier Type: -
Identifier Source: org_study_id