The OneFreeze Study (OneFreeze)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation
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
Sites / Locations
- University of California, San Francisco
- Virginia Mason Medical Center
- Montreal Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
two 3-minute cryoablations
One 3-minute cryoablation
Arm Description
two 3-minute cryoablations per pulmonary vein during an atrial fibrillation ablation procedure
One 3-minute cryoablation per pulmonary vein during an atrial fibrillation ablation procedure
Outcomes
Primary Outcome Measures
Composite Score of Adverse Events
Composite score of adverse events (Range 0-20 points) will be calculated after the patient has completed follow-up. Higher scores indicate greater severity.
Luminal Esophageal Temperature (LET) (0-2 points): 1-point if ≤20 degrees C, 2-points if ≤15 degrees C
Phrenic nerve injury (0-3 points): 1-point if ≥30% decrease in compound muscle action potential (CMAP) or loss of phrenic nerve capture resulting in cessation of freeze (without movement of pacing catheter), 2-points if Phrenic nerve palsy lasting> 1 minute resolving on table, 3-points if Phrenic nerve palsy not resolving on the table
Pulmonary (0-4 points): 1-point if persistent dry cough > 1 week post ablation, 4-points if Hemoptysis
Gastrointestinal (GI) (0-6 points): 1-point if Gastroparesis symptoms, 3-points if Esophageal ulceration, 6-points if left atrial-esophageal fistula
Pulmonary vein (PV) stenosis (0-5 points): 1-point if ≥50% luminal area, 4-points if ≥90% luminal area, 5-points if total occlusion
Secondary Outcome Measures
Participants free from symptomatic atrial fibrillation (AF)
Participants experiencing no episodes of AF greater than 30 seconds, excluding episodes documented in the blanking period (6 weeks post-ablation for paroxysmal AF patients).
Atrial Fibrillation (AF) burden
AF burden is defined as the overall percentage of AF during the 14-day observed period on Holter monitoring at 6 months and 12 months.
Procedure Time
The duration of the Pulmonary Vein Isolation procedure from first leg puncture to removal of ablation catheter
Left Atrial Access time
Time it takes to gain transseptal access during the catheter ablation procedure
Fluoroscopy Time
The amount of time in minutes (and milligray (mGy)/millisievert (mSv) dosage) of fluoroscopy used during the procedure
Number of cryoablations needed to isolate each vein
Number of cryoablations needed to isolate each vein
Acute success of the Pulmonary Vein Isolation (PVI)
percentage of pulmonary veins isolated during the catheter ablation procedure
Individual Adverse Events
Number and severity of adverse events following the PVI procedure during the 12-month follow-up window
Number of re-isolations required
Number of pulmonary veins requiring touch up for re-isolation after initial isolation was achieved.
Full Information
NCT ID
NCT02217254
First Posted
August 8, 2014
Last Updated
September 18, 2023
Sponsor
University of California, San Francisco
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT02217254
Brief Title
The OneFreeze Study
Acronym
OneFreeze
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
two 3-minute cryoablations
Arm Type
Active Comparator
Arm Description
two 3-minute cryoablations per pulmonary vein during an atrial fibrillation ablation procedure
Arm Title
One 3-minute cryoablation
Arm Type
Active Comparator
Arm Description
One 3-minute cryoablation per pulmonary vein during an atrial fibrillation ablation procedure
Intervention Type
Procedure
Intervention Name(s)
Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System
Other Intervention Name(s)
Pulmonary vein isolation, Cryoballoon catheter ablation
Primary Outcome Measure Information:
Title
Composite Score of Adverse Events
Description
Composite score of adverse events (Range 0-20 points) will be calculated after the patient has completed follow-up. Higher scores indicate greater severity.
Luminal Esophageal Temperature (LET) (0-2 points): 1-point if ≤20 degrees C, 2-points if ≤15 degrees C
Phrenic nerve injury (0-3 points): 1-point if ≥30% decrease in compound muscle action potential (CMAP) or loss of phrenic nerve capture resulting in cessation of freeze (without movement of pacing catheter), 2-points if Phrenic nerve palsy lasting> 1 minute resolving on table, 3-points if Phrenic nerve palsy not resolving on the table
Pulmonary (0-4 points): 1-point if persistent dry cough > 1 week post ablation, 4-points if Hemoptysis
Gastrointestinal (GI) (0-6 points): 1-point if Gastroparesis symptoms, 3-points if Esophageal ulceration, 6-points if left atrial-esophageal fistula
Pulmonary vein (PV) stenosis (0-5 points): 1-point if ≥50% luminal area, 4-points if ≥90% luminal area, 5-points if total occlusion
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Participants free from symptomatic atrial fibrillation (AF)
Description
Participants experiencing no episodes of AF greater than 30 seconds, excluding episodes documented in the blanking period (6 weeks post-ablation for paroxysmal AF patients).
Time Frame
6 months and 12 months
Title
Atrial Fibrillation (AF) burden
Description
AF burden is defined as the overall percentage of AF during the 14-day observed period on Holter monitoring at 6 months and 12 months.
Time Frame
6 months, 12 months
Title
Procedure Time
Description
The duration of the Pulmonary Vein Isolation procedure from first leg puncture to removal of ablation catheter
Time Frame
4 - 8 hours
Title
Left Atrial Access time
Description
Time it takes to gain transseptal access during the catheter ablation procedure
Time Frame
4 - 8 hours
Title
Fluoroscopy Time
Description
The amount of time in minutes (and milligray (mGy)/millisievert (mSv) dosage) of fluoroscopy used during the procedure
Time Frame
4 - 8 hours
Title
Number of cryoablations needed to isolate each vein
Description
Number of cryoablations needed to isolate each vein
Time Frame
4 - 8 hours
Title
Acute success of the Pulmonary Vein Isolation (PVI)
Description
percentage of pulmonary veins isolated during the catheter ablation procedure
Time Frame
4 - 8 hours
Title
Individual Adverse Events
Description
Number and severity of adverse events following the PVI procedure during the 12-month follow-up window
Time Frame
within 12 months after the Pulmonary Vein Isolation (PVI)
Title
Number of re-isolations required
Description
Number of pulmonary veins requiring touch up for re-isolation after initial isolation was achieved.
Time Frame
4 - 8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byron K Lee, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94122
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Montreal Heart Institute
City
Québec
Country
Canada
12. IPD Sharing Statement
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The OneFreeze Study
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