NCT02217254

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

5 years

First QC Date

August 8, 2014

Last Update Submit

September 18, 2023

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Participants free from symptomatic atrial fibrillation (AF)

    6 months and 12 months

  • Atrial Fibrillation (AF) burden

    6 months, 12 months

  • Procedure Time

    4 - 8 hours

  • Left Atrial Access time

    4 - 8 hours

  • Fluoroscopy Time

    4 - 8 hours

  • +4 more secondary outcomes

Study Arms (2)

two 3-minute cryoablations

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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

Interventions

Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation SystemPROCEDURE
Also known as: Pulmonary vein isolation, Cryoballoon catheter ablation
One 3-minute cryoablationtwo 3-minute cryoablations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, San Francisco

San Francisco, California, 94122, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Montreal Heart Institute

Québec, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Byron K Lee, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 15, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

CA(1)US(2)