Paroxysmal Atrial FibrillationOneFreezeNCT02217254
The OneFreeze Study
A study testing Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System in people with Paroxysmal Atrial Fibrillation, run by University of California, San Francisco at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2014to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of California, San Francisco
San Francisco, California, 94122
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
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
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.
Read the 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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation SystemProcedure or surgery
Also called Pulmonary vein isolation, Cryoballoon catheter ablation
| Study group | Role | What they receive |
|---|---|---|
| two 3-minute cryoablations | Active comparator | two 3-minute cryoablations per pulmonary vein during an atrial fibrillation ablation procedure Receives: 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 Receives: Procedure: Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (9)
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).
Measured: 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.
Measured: 6 months, 12 months
Procedure Time
The duration of the Pulmonary Vein Isolation procedure from first leg puncture to removal of ablation catheter
Measured: 4 - 8 hours
Left Atrial Access time
Time it takes to gain transseptal access during the catheter ablation procedure
Measured: 4 - 8 hours
Fluoroscopy Time
The amount of time in minutes (and milligray (mGy)/millisievert (mSv) dosage) of fluoroscopy used during the procedure
Measured: 4 - 8 hours
Number of cryoablations needed to isolate each vein
Number of cryoablations needed to isolate each vein
Measured: 4 - 8 hours
Acute success of the Pulmonary Vein Isolation (PVI)
percentage of pulmonary veins isolated during the catheter ablation procedure
Measured: 4 - 8 hours
Individual Adverse Events
Number and severity of adverse events following the PVI procedure during the 12-month follow-up window
Measured: 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.
Measured: 4 - 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Byron K Lee, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217254
- Sponsor's protocol ID
- UC-OF01
- Acronym
- OneFreeze
- Status last verified
- Sep 2023
- First submitted
- 8 Aug 2014
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02217254
- Acronym / sponsor ID
- OneFreeze / UC-OF01
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| two 3-minute cryoablations | Active comparator | Procedure: Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation Systemtwo 3-minute cryoablations per pulmonary vein during an atrial fibrillation ablation procedure |
| One 3-minute cryoablation | Active comparator | Procedure: Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation SystemOne 3-minute cryoablation per pulmonary vein during an atrial fibrillation ablation procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation SystemAlso: Pulmonary vein isolation, Cryoballoon catheter ablation | Procedure or surgery | One 3-minute cryoablation, two 3-minute cryoablations |
Primary outcome
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
9 secondary outcomes
Participants free from symptomatic atrial fibrillation (AF)
Time frame: 6 months and 12 months
Atrial Fibrillation (AF) burden
Time frame: 6 months, 12 months
Procedure Time
Time frame: 4 - 8 hours
Left Atrial Access time
Time frame: 4 - 8 hours
Fluoroscopy Time
Time frame: 4 - 8 hours
Number of cryoablations needed to isolate each vein
Time frame: 4 - 8 hours
Acute success of the Pulmonary Vein Isolation (PVI)
Time frame: 4 - 8 hours
Individual Adverse Events
Time frame: within 12 months after the Pulmonary Vein Isolation (PVI)
Number of re-isolations required
Time frame: 4 - 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byron K Lee, MD principal investigator
University of California, San Francisco
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System in people with Paroxysmal Atrial Fibrillation, run by University of California, San Francisco at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Score of Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.