The OneFreeze Study

Not Applicable

Completed

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

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
two 3-minute cryoablations	Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System	two 3-minute cryoablations per pulmonary vein during an atrial fibrillation ablation procedure
One 3-minute cryoablation	Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System	One 3-minute cryoablation per pulmonary vein during an atrial fibrillation ablation procedure

Primary Outcome Measures

Name	Time	Method
Composite Score of Adverse Events	12 months	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

Name	Time	Method
Participants free from symptomatic atrial fibrillation (AF)	6 months and 12 months	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	6 months, 12 months	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	4 - 8 hours	The duration of the Pulmonary Vein Isolation procedure from first leg puncture to removal of ablation catheter
Left Atrial Access time	4 - 8 hours	Time it takes to gain transseptal access during the catheter ablation procedure
Fluoroscopy Time	4 - 8 hours	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	4 - 8 hours	Number of cryoablations needed to isolate each vein
Acute success of the Pulmonary Vein Isolation (PVI)	4 - 8 hours	percentage of pulmonary veins isolated during the catheter ablation procedure
Individual Adverse Events	within 12 months after the Pulmonary Vein Isolation (PVI)	Number and severity of adverse events following the PVI procedure during the 12-month follow-up window
Number of re-isolations required	4 - 8 hours	Number of pulmonary veins requiring touch up for re-isolation after initial isolation was achieved.

Locations (3): University of California, San Francisco
🇺🇸
San Francisco, California, United States
Montreal Heart Institute
🇨🇦
Québec, Canada
Virginia Mason Medical Center
🇺🇸
Seattle, Washington, United States