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Atrial FibrillationNCT03012841

STOP Persistent AF

A study testing Arctic Front Advance Cardiac CryoAblation Catheter in people with Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 25 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation (AF). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Arctic Front Advance Cardiac CryoAblation Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
25 sitesin 3 countries
Study dates
2 Mar 2017to 13 Aug 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF
  • Failure or intolerance of at least one Class I or III antiarrhythmic drug
  • Age 18 or older (or older than 18 if required by local law)

Who cannot join

  • Left atrial diameter > 5.0 cm (anteroposterior)
  • Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
  • Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
  • Presence of any pulmonary vein stents
  • Presence of any pre-existing pulmonary vein stenosis
  • Pre-existing hemidiaphragmatic paralysis
Show all 26Show fewer
  • Presence of any cardiac valve prosthesis
  • +3 and +4 mitral valve regurgitation or stenosis
  • Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding the consent date
  • Unstable angina
  • New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. Transthoracic echocardiogram (TTE))
  • Primary pulmonary hypertension
  • Rheumatic heart disease
  • Thrombocytosis, thrombocytopenia
  • Any condition contraindicating chronic anticoagulation
  • Active systemic infection
  • Hypertrophic cardiomyopathy
  • Cryoglobulinemia
  • Uncontrolled hyperthyroidism
  • Any cerebral ischemic event (strokes or transient ischemic attacks (TIAs)) which occurred during the 6 month interval preceding the consent date
  • Any woman known to be pregnant or breastfeeding, or any woman of child bearing potential who is not on a reliable form of birth regulation method or abstinence
  • Life expectancy less than one year
  • Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
  • Known allergies or hypersensitivities to adhesives
  • Known drug or alcohol dependency
  • Unwilling or unable to comply fully with study procedures and follow-up

Trial locations and contacts

25 sites in 3 countries.

25 sites in 3 countries

United States19 sites

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28803

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287-0005

  • Cardiac Arrhythmia Service

    Boca Raton, Florida, 33432

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Northwestern University

    Chicago, Illinois, 60611

  • Baylor Research Institute

    Dallas, Texas, 75226

  • Doylestown Health Cardiology

    Doylestown, Pennsylvania, 18901

  • Englewood Hospital & Medical Center

    Englewood, New Jersey, 07631-1808

  • NorthShore University Health System

    Evanston, Illinois, 60201-1718

  • Saint Vincent's Medical Center

    Jacksonville, Florida, 32204

  • St. Luke's Health System

    Kansas City, Missouri, 64111

  • Colorado Heart and Vascular

    Lakewood, Colorado, 80228

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-8802

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Northwell Health (Lenox Hill Hospital and Staten Island University Hospital)

    New York, New York, 10075-1851

  • Banner-University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Swedish Medical Center

    Seattle, Washington, 98122

Other trials in United States

Canada3 sites

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec, G1V 4G5

  • Victoria Cardiac Arrhythmia Trials

    Victoria, British Columbia, V8T 1Z4

Other trials in Canada

Japan3 sites

  • Tokyo Medical and Dental University

    Bunkyō, Tokyo, 113-8519

  • Jikei University Hospital

    Tokyo

  • Yokohama City Minato Red Cross Hospital

    Yokohama, 231-8682

Other trials in Japan

About this study

To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation (AF).

Being tested
Arctic Front Advance Cardiac CryoAblation Catheter
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arctic Front Advance Cardiac CryoAblation CatheterDevice

    Also called Freezor MAX Cardiac CryoAblation Catheter

    Cryoablation

Study groups in NCT03012841
Study groupRoleWhat they receive
Treatment ArmExperimentalSubjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
Receives: Device: Arctic Front Advance Cardiac CryoAblation Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.

    Treatment failure is defined as any of the following components:

    • Acute procedural failure
    • Documented AF/atrial tachycardia (AT)/atrial flutter (AFL) after the 90 day blanking period
    • A reablation for the treatment of recurrent AF/AT/AFL after the 90 day blanking period
    • Class I or III antiarrhythmic drug (AAD) dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new Class I or III AAD after the 90 day blanking period.
    • Ablation using radiofrequency (RF) in the left atrium

    Blanking period is defined as the first 90 days after the index ablation procedure.

    Acute procedural failure is defined as:

    • Inability to isolate all accessible targeted pulmonary veins (minimally assessed for entrance block and, where assessable, exit block) during the index procedure
    • Left atrial non-PVI ablations including but not limited to, ablation of linear lesions complex fractionated electrograms or non-PV triggers

    Measured: 12 Months

  2. Percent of Subjects Free From a Primary Safety Event at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.

    A primary safety event is defined as a serious procedure-related or serious system-related adverse event including the following:

    • Transient ischemic attack (within 7 days of ablation procedure)
    • Cerebrovascular accident (within 7 days of ablation procedure)
    • Major bleeding that requires transfusion (within 7 days of ablation procedure)
    • Cardiac perforation, tamponade or pericardial effusion (within 7 days of ablation procedure)
    • Pulmonary vein stenosis (> 75% reduction within 12-months of ablation procedure)
    • Myocardial infarction (within 7 days of ablation procedure)
    • Phrenic nerve injury (unresolved at 12-months)
    • Atrio-esophageal fistula (within 12-months of ablation procedure)
    • Death (within 7 days of ablation procedure)

    Measured: 12 months

Secondary outcomes (3)

  1. Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)

    Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire completed at baseline and 12 month visits. The AFEQT instrument yields scores from 0 (representing the worst possible debilitation from AF) to 100 (representing no reduction in quality of life from AF).

    Measured: Baseline and 12 months

  2. Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component

    Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).

    Measured: Baseline and 12 months

  3. Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component

    Medical Outcome Study Short Form-12 (SF-12) questionnaire completed at baseline and 12 month visits. The SF-12 instrument has two composite scores, one for physical health and one for mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2017 (estimated)
  2. Study start2 Mar 2017
  3. Primary completion13 Aug 2019
  4. Study completion13 Aug 2019

Resources

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
Not applicable
Intervention model
Single group
Model description
Arctic Front Advance Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation Catheter
Masking
None (open label)
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03012841
Sponsor's protocol ID
STOP Persistent AF
Status last verified
Feb 2025
First submitted
22 Dec 2016
Last updated
13 Feb 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Su WW, Reddy VY, Bhasin K, Champagne J, Sangrigoli RM, Braegelmann KM, Kueffer FJ, Novak P, Gupta SK, Yamane T, Calkins H; STOP Persistent AF Investigators. Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. Heart Rhythm. 2020 Nov;17(11):1841-1847. doi: 10.1016/j.hrthm.2020.06.020. Epub 2020 Jun 24.

    PubMed 32590151

Questions about this trial

What is this clinical trial studying?

A study testing Arctic Front Advance Cardiac CryoAblation Catheter in people with Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 25 sites in 3 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 3 inclusion and 26 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 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Canada, Japan. 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?

Yes. Results are posted in the registry (first posted 21 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure. (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03012841, which also lists 1 linked publication.

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 13 Feb 2025.

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