The OneFreeze Study

Completed · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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 fibrillation.

Key facts

Study ID

NCT02217254

Run by

University of California, San Francisco

People needed

90

Starts

2014-10-01

Expected to finish

2019-10-01

Last updated by the study team

2023-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Montreal Heart Institute — Québec, Canada

Full record on ClinicalTrials.gov

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