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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COMPLETED
NA
90 participants
INTERVENTIONAL
2014-10-31
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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two 3-minute cryoablations
two 3-minute cryoablations per pulmonary vein during an atrial fibrillation ablation procedure
Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System
One 3-minute cryoablation
One 3-minute cryoablation per pulmonary vein during an atrial fibrillation ablation procedure
Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System
Interventions
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Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Life expectancy ≥ 1 year
* Willing and able to return to and comply with scheduled follow-up visits
* Willing and able to provide written informed consent
Exclusion Criteria
* History of previous pulmonary vein isolation ablation for atrial fibrillation
* History of MAZE procedure
* Left ventricular EF ≤ 35% within the past 12 months
* Mechanical mitral valve
* Single PV \> 30 mm in diameter, unless deemed appropriate by the site PI
* Stroke/TIA within the past 6 months
* Creatinine \> 2.0 mg/dL within the past 6 months
* Pregnancy or desire to get pregnant within the next 12 months
* Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this study
* Mental impairment or other conditions, which may not allow the participant to understand the nature, significance and scope of the study
* Any other condition or circumstance that in the judgment of the Clinical Site Investigator that makes the participant unsuitable for the study
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Byron K Lee, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Montreal Heart Institute
Québec, , Canada
Countries
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Other Identifiers
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UC-OF01
Identifier Type: -
Identifier Source: org_study_id
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