Status:
COMPLETED
The OneFreeze Study
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Medtronic
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The One Freeze study is a prospective multi-center randomized controlled trial to assess the safety and efficacy of one vs. two cryoablations per pulmonary vein for the treatment of atrial fibrillatio...
Detailed Description
The One Freeze Trial is an investigator-initiated trial that has been developed by the Principals at the University of California, San Francisco (UCSF) and with full participation of the Steering Comm...
Eligibility Criteria
Inclusion
- Paroxysmal atrial fibrillation
- 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
- History of \> 5 electric cardioversions
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02217254
Start Date
October 1 2014
End Date
October 1 2019
Last Update
September 21 2023
Active Locations (3)
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1
University of California, San Francisco
San Francisco, California, United States, 94122
2
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
3
Montreal Heart Institute
Québec, Canada