An interventional study of Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System in Paroxysmal Atrial Fibrillation, sponsored by University of California, San Francisco. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 90 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
two 3-minute cryoablations per pulmonary vein during an atrial fibrillation ablation procedure
Procedure: Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System
One 3-minute cryoablation per pulmonary vein during an atrial fibrillation ablation procedure
Procedure: Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System
Also known as: Pulmonary vein isolation, Cryoballoon catheter ablation
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
Time frame: 12 months
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).
Time frame: 6 months and 12 months
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.
Time frame: 6 months, 12 months
Procedure Time
The duration of the Pulmonary Vein Isolation procedure from first leg puncture to removal of ablation catheter
Time frame: 4 - 8 hours
Left Atrial Access time
Time it takes to gain transseptal access during the catheter ablation procedure
Time frame: 4 - 8 hours
Fluoroscopy Time
The amount of time in minutes (and milligray (mGy)/millisievert (mSv) dosage) of fluoroscopy used during the procedure
Time frame: 4 - 8 hours
Number of cryoablations needed to isolate each vein
Number of cryoablations needed to isolate each vein
Time frame: 4 - 8 hours
Acute success of the Pulmonary Vein Isolation (PVI)
percentage of pulmonary veins isolated during the catheter ablation procedure
Time frame: 4 - 8 hours
Individual Adverse Events
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)
Number of re-isolations required
Number of pulmonary veins requiring touch up for re-isolation after initial isolation was achieved.
Time frame: 4 - 8 hours
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco