The OneFreeze Study

Paroxysmal Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217254
• Other study ID #: UC-OF01
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: October 2019

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Québec
United States	University of California, San Francisco	San Francisco	California
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Medtronic

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	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).	6 months and 12 months
Secondary	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.	6 months, 12 months
Secondary	Procedure Time	The duration of the Pulmonary Vein Isolation procedure from first leg puncture to removal of ablation catheter	4 - 8 hours
Secondary	Left Atrial Access time	Time it takes to gain transseptal access during the catheter ablation procedure	4 - 8 hours
Secondary	Fluoroscopy Time	The amount of time in minutes (and milligray (mGy)/millisievert (mSv) dosage) of fluoroscopy used during the procedure	4 - 8 hours
Secondary	Number of cryoablations needed to isolate each vein	Number of cryoablations needed to isolate each vein	4 - 8 hours
Secondary	Acute success of the Pulmonary Vein Isolation (PVI)	percentage of pulmonary veins isolated during the catheter ablation procedure	4 - 8 hours
Secondary	Individual Adverse Events	Number and severity of adverse events following the PVI procedure during the 12-month follow-up window	within 12 months after the Pulmonary Vein Isolation (PVI)
Secondary	Number of re-isolations required	Number of pulmonary veins requiring touch up for re-isolation after initial isolation was achieved.	4 - 8 hours