The OneFreeze Study

University of California San Francisco (UCSF)

Status

Completed

Conditions

Paroxysmal Atrial Fibrillation

Treatments

Procedure: Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02217254

UC-OF01

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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