Clinical trial NCT02217254: The OneFreeze Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2014-08-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 fibrillation.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite Score of Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Participants free from symptomatic atrial fibrillation (AF)
timeFrame: 6 months and 12 months
measure: Atrial Fibrillation (AF) burden
timeFrame: 6 months, 12 months
measure: Procedure Time
timeFrame: 4 - 8 hours
measure: Left Atrial Access time
timeFrame: 4 - 8 hours
measure: Fluoroscopy Time
timeFrame: 4 - 8 hours
measure: Number of cryoablations needed to isolate each vein
timeFrame: 4 - 8 hours
measure: Acute success of the Pulmonary Vein Isolation (PVI)
timeFrame: 4 - 8 hours
measure: Individual Adverse Events
timeFrame: within 12 months after the Pulmonary Vein Isolation (PVI)
measure: Number of re-isolations required
timeFrame: 4 - 8 hours
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Québec
country: Canada
facility: Montreal Heart Institute
Study officials:
affiliation: University of California, San Francisco
name: Byron K Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: