AzTrials
AzTrials

Paroxysmal Atrial Fibrillation (PAF)STOP AF PASNCT01456949

Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)

A study testing Medtronic Arctic Front® Cardiac CryoAblation System in people with Paroxysmal Atrial Fibrillation (PAF), run by Medtronic Cardiac Ablation Solutions at 39 sites in 2 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

The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Paroxysmal Atrial Fibrillation (PAF)
What is being tested?
Medtronic Arctic Front® Cardiac CryoAblation System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
39 sitesin 2 countries
Study dates
26 Jun 2012to 30 Nov 2017
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

  • Documented PAF:
  • Diagnosis of paroxysmal atrial fibrillation (PAF), AND
  • 2 or more episodes of AF during the 3 months preceding the consent Date, AND
  • At least 1 episode of AF documented with a tracing within 12 months preceding the consent date.
  • Age 18 years or older
  • Failure for the treatment of AF (effectiveness or intolerance) of at least one membrane active AAD for rhythm control.

Who cannot join

  • Any previous left atrial (LA) ablation (except permissible retreatment subjects)
  • Any previous LA surgery
  • Current intracardiac thrombus (can be treated after thrombus is resolved)
  • Presence of any pulmonary vein stents
  • Presence of any pre-existing pulmonary vein stenosis
  • Pre-existing hemidiaphragmatic paralysis
Show all 29Show fewer
  • Anteroposterior LA diameter > 5.5 cm by TTE
  • Presence of any cardiac valve prosthesis
  • Clinically significant mitral valve regurgitation or stenosis
  • Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
  • Unstable angina
  • Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
  • Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
  • NYHA class III or IV congestive heart failure
  • Left ventricular ejection fraction (LVEF) < 40%
  • 2º (Type II) or 3º atrioventricular block
  • Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
  • Brugada syndrome
  • Long QT syndrome
  • Arrhythmogenic right ventricular dysplasia
  • Sarcoidosis
  • Hypertrophic cardiomyopathy
  • Known cryoglobulinemia
  • Uncontrolled hyperthyroidism
  • Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.
  • Any woman known to be pregnant
  • Life expectancy less than one (1) year
  • Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
  • Unwilling or unable to comply fully with study procedures and followup

Trial locations and contacts

39 sites in 2 countries.

39 sites in 2 countries

United States32 sites

  • Alaska Heart Institute

    Anchorage, Alaska, 99508

  • Asheville Cardiology Associate PA

    Asheville, North Carolina, 28803

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Capital Cardiovascular Associates

    Camp Hill, Pennsylvania, 17011

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Bethesda North Hospital l TriHealth Hatton Institute

    Cincinnati, Ohio, 45242

  • Columbia Heart Clinic

    Columbia, South Carolina, 29203

  • Metropolitan Cardiology Consultants PA

    Coon Rapids, Minnesota, 55433

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Daytona Heart Group

    Daytona Beach, Florida, 32114

  • Colorado Heart and Vascular

    Denver, Colorado, 80204

  • Doylestown Cardiology Associates

    Doylestown, Pennsylvania, 18901

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22031

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • University of Florida

    Gainesville, Florida, 32610

  • Stern Cardiovascular

    Germantown, Tennessee, 38138

  • Saint Luke's Episcopal Hospital - Texas Medical Center

    Houston, Texas, 77030

  • Lancaster Heart & Stroke

    Lancaster, Pennsylvania, 17602

  • Bryan LGH

    Lincoln, Nebraska, 68506

  • WellStar Kennestone Hospital

    Marietta, Georgia, 30060

  • Saint Thomas Research Institute

    Nashville, Tennessee, 37205

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Baylor Research Institute

    Plano, Texas, 75093

  • St. Mary's Hospital - Mayo Clinic

    Rochester, Minnesota, 55902

  • HealthEast St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • Good Samaritan Hospital

    San Jose, California, 95124

  • Memorial Advanced Cardiovascular Institute

    South Bend, Indiana, 46601

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

Other trials in United States

Canada7 sites

  • Royal Alexandra Hospital

    Edmonton, Alberta

  • Hôpital du Sacre Coeur de Montreal

    Montreal, Quebec

  • McGill University Health Centre

    Montreal, Quebec

  • Montreal Heart Institute

    Montreal, Quebec

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec, Quebec

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Victoria Cardiac Arrhythmia Trials Inc

    Victoria, British Columbia

Other trials in Canada

About this study

The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.

Read the detailed description

Safety and effectiveness will be evaluated against pre-specified performance criteria as determined by the sponsor and FDA. The criteria set in this study have been previously used to demonstrate safety and effectiveness in cryoablation and radio-frequency ablation for the treatment of paroxysmal atrial fibrillation.

The analyses of the primary effectiveness objective will take place once all the subjects with a study cryoablation procedure attempt have reached 36 months of follow-up post-cryoablation procedure. The analysis of the primary safety objective will take place once all the subjects with a study cryoablation procedure attempt have reached 12 months of follow-up post-cryoablation procedure. The analyses for the secondary objectives will take place once all subjects with a study cryoablation attempt have reached 36 months of follow-up post-cryoablation procedure.

Being tested
Medtronic Arctic Front® Cardiac CryoAblation System
Keywords
Atrial fibrillation (AF), Paroxysmal atrial fibrillation (PAF), Arrythmias, Cardiac Arrythmias, Cardiac ablation, Cryoablation
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • Medtronic Arctic Front® Cardiac CryoAblation SystemDevice

    Also called Medtronic CryoCath CryoConsole, Arctic Front® Cardiac CryoAblation Catheter, Arctic Front Advance™ Cardiac CryoAblation Catheter, Freezor® MAX Cardiac CryoAblation Catheter

    Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed.

Study groups in NCT01456949
Study groupRoleWhat they receive
Single ArmOtherCryoablation
Receives: Device: Medtronic Arctic Front® Cardiac CryoAblation System

What is being measured

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

  1. Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) Through 36 Months

    Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).

    Chronic treatment failure is defined as:

    • Documented atrial fibrillation lasting longer than 30 seconds (outside the 90 day blanking period) OR
    • Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)

    Measured: Through 36 months

  2. Safety: Percentage of Participants Experiencing Cryoablation Procedure Events (CPEs) Through 12 Months

    Demonstrate safety (through 12 months) of Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the rate of subjects experiencing Cryoablation Procedure Events (CPEs) with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).

    Measured: 12 Months

Secondary outcomes (2)

  1. Chronic Safety: Percentage of Participants Free From Major Atrial Fibrillation Events (MAFE) at 1, 2 and 3 Years.

    Freedom from Major Atrial Fibrillation Event (MAFE): A MAFE is a serious adverse event (SAE) which has not been categorized as a cryoablation procedure event.

    Measured: Annually, through 3 years

  2. Chronic Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) at 1 and 2 Years

    Freedom from chronic treatment failure, defined as:

    • Documented atrial fibrillation lasting longer than 30 seconds (outside the 90 day blanking period) OR
    • Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)

    Measured: Annually, at 1 and 2 years

Timeline

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

  1. First posted21 Oct 2011 (estimated)
  2. Study start26 Jun 2012
  3. Primary completion30 Nov 2017
  4. Study completion30 Nov 2017

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
Masking
None (open label)
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01456949
Sponsor's protocol ID
STOP AF PAS
Acronym
STOP AF PAS
Status last verified
Feb 2025
First submitted
19 Oct 2011
Last updated
13 Feb 2025
Data monitoring committee
Yes

Publications

  • Knight BP, Novak PG, Sangrigoli R, Champagne J, Dubuc M, Adler SW, Svinarich JT, Essebag V, Hokanson R, Kueffer F, Jain SK, John RM, Mansour M; STOP AF PAS Investigators. Long-Term Outcomes After Ablation for Paroxysmal Atrial Fibrillation Using the Second-Generation Cryoballoon: Final Results From STOP AF Post-Approval Study. JACC Clin Electrophysiol. 2019 Mar;5(3):306-314. doi: 10.1016/j.jacep.2018.11.006. Epub 2018 Dec 26.

    PubMed 30898232

Questions about this trial

What is this clinical trial studying?

A study testing Medtronic Arctic Front® Cardiac CryoAblation System in people with Paroxysmal Atrial Fibrillation (PAF), run by Medtronic Cardiac Ablation Solutions at 39 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 6 inclusion and 29 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 39 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?

Yes. Results are posted in the registry (first posted 11 Jan 2019). 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?

Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) Through 36 Months (time frame: Through 36 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 NCT01456949, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in