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Completed

NCT Number: NCT02217254

The OneFreeze Study

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Heart Institute, Québec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System

Procedure

Other names: Pulmonary vein isolation, Cryoballoon catheter ablation

Primary outcomes

  1. Composite Score of Adverse Events

    Time frame: 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 outcomes

  1. Participants free from symptomatic atrial fibrillation (AF)

    Time frame: 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).

  2. Atrial Fibrillation (AF) burden

    Time frame: 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.

  3. Procedure Time

    Time frame: 4 - 8 hours

    The duration of the Pulmonary Vein Isolation procedure from first leg puncture to removal of ablation catheter

  4. Left Atrial Access time

    Time frame: 4 - 8 hours

    Time it takes to gain transseptal access during the catheter ablation procedure

  5. Fluoroscopy Time

    Time frame: 4 - 8 hours

    The amount of time in minutes (and milligray (mGy)/millisievert (mSv) dosage) of fluoroscopy used during the procedure

  6. Number of cryoablations needed to isolate each vein

    Time frame: 4 - 8 hours

    Number of cryoablations needed to isolate each vein

  7. Acute success of the Pulmonary Vein Isolation (PVI)

    Time frame: 4 - 8 hours

    percentage of pulmonary veins isolated during the catheter ablation procedure

  8. Individual Adverse Events

    Time frame: 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

  9. Number of re-isolations required

    Time frame: 4 - 8 hours

    Number of pulmonary veins requiring touch up for re-isolation after initial isolation was achieved.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Medtronic

Registry information

Official study 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

Acronym: OneFreeze

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2014
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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