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The OneFreeze Study — OneFreeze  

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
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

Clinical Trial 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 fibrillation.

Clinical Trial 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 Committee. One Freezel is a prospective multicenter randomized controlled trial with a goal to enroll and randomize a minimum of 90 study participants. Participants will be randomized in a 1:1 ratio to either PVI with a single freeze per pulmonary vein (1F Group) or to PVI with at least two freezes per pulmonary vein (2F Group). The One Freeze study's primary aim is to determine if one 3-minute cryoablation per pulmonary vein results in a lower composite adverse event score as compared to the traditional method of using two 3-minute cryoablations per pulmonary vein. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02217254
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase N/A
Start date October 2014
Completion date October 2019
View Details
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