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Paroxysmal Atrial FibrillationPhase 3Stop-AFNCT00523978

A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation

A Phase 3 study testing Arctic Front® Cryoablation Catheter and Flecainide or Sotalol or Propafenone in people with Paroxysmal Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 26 sites in 2 countries.

Completed

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

Official record
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Trial summary

This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada. Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy failure of one or more Study Atrial… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Paroxysmal Atrial Fibrillation
What is being tested?
Arctic Front® Cryoablation Catheter and Flecainide or Sotalol or Propafenone
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
245 participants
Where
26 sitesin 2 countries
Study dates
Oct 2006to Jul 2011
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented Paroxysmal Atrial Fibrillation (PAF): PAF diagnosis, 2 episodes of PAF within the last 2 months, at least 1 episode of PAF must be documented
  • Age 18-75
  • Documented Effectiveness Failure of one (1) AF drug
  • Willing to be randomized to either group and do full 12 month follow-up
  • Able to follow standardized AF drug protocol

Who cannot join

  • Any cardioversion within 3 months or more than 2 within 2 years
  • Amiodarone within 6 months
  • LA size > 5.0cm
  • Previous LA ablation/surgery, structural heart disease, heart failure class III or IV
  • Hypertrophic cardiomyopathy, Mitral prosthesis
  • Unstable angina, uncontrolled hyperthyroidism
Show all 12Show fewer
  • Stroke or TIA within 6 months, MI within 2 months, cardiac surgery within 3 months
  • Thrombocytosis, thrombocytopenia
  • Any condition contraindicating chronic anticoagulation
  • EF <40%
  • Pregnancy
  • Life expectancy <1year

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States23 sites

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • Emery Crawford Long Hospital

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • University of Alabama

    Birmingham, Alabama, 35294-0007

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Colorado Cardiac Alliance -- Memorial Hospital

    Colorado Springs, Colorado, 80907

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Iowa Heart Center

    Des Moines, Iowa, 50314

  • Inova Research Center

    Falls Church, Virginia, 22042

  • Cardiology Associates of Green Bay

    Green Bay, Wisconsin, 54301-3596

  • Mayo Clinic- Jacksonville

    Jacksonville, Florida, 32224

  • Cedar Sinai Medical Center

    Los Angeles, California, 90048

  • Arrhythmia Center of Southern WI

    Milwaukee, Wisconsin, 53215

  • Sentara CV Research Institute

    Norfolk, Virginia, 23507

  • University of Pennsylvania Health

    Philadelphia, Pennsylvania, 19104-4283

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • Medical College of Virginia

    Richmond, Virginia, 23219

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • UC Davis Medical Center

    Sacramento, California, 98517

  • Stanford Hospital

    Stanford, California, 94305-5233

  • BayHeart Group -- St-Joseph's Hospital

    Tampa, Florida, 33607

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

Canada3 sites

  • London Medical Health Sciences

    London, Ontario, N6A5A5

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Laval Hospital

    Ste-Foy, Quebec, G1V 4G5

Other trials in Canada

About this study

Official title: A Randomized, Controlled Clinical Trial of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation.

This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada. Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or sotalol) were randomized 2:1 to cryoablation intervention (Experimental Subjects, ES) or to a Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90 days after study therapy was initiated was considered a blanked period for all subjects.

Read the detailed description

STOP AF (PS-023) is a randomized, controlled study of subjects 18 to 75 years old who had been referred for ablative intervention after failing one or two (but not all three) anti-arrhythmic drugs used in the treatment of AF (flecainide, propafenone and sotalol). Study subjects were randomized into two arms: the cryoablation (treatment) arm and the membrane-active antiarrhythmic drug (control) arm. A 90- day blanked follow-up period, including reablation and medication adjustments was applied in both arms to optimize therapies. All subjects underwent follow-up assessments at 1, 3, 6, 9 and 12 months, weekly transtelephonic monitoring, 24-hour Holter monitoring and CT/MRI of the pulmonary veins(at 6 and 12 months) during the trial period. Control subjects who were confirmed to be chronic treatment failures were permitted to crossover to cryoablation in this trial.

Acute procedural success was defined for subjects that underwent cryoablation and demonstrated electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure using the Arctic Front® Cardiac CryoAblation Catheter System.

The primary effectiveness endpoint was defined as having acute procedural success and freedom from chronic treatment failure (CTF) for experimental subjects, and freedom from CTF for control subjects. Freedom from (CTF) was defined for both groups as the occurrence of detectable AF during a non-blanked follow-up period, or an AF Intervention, or the use of a non-study AF drug at any time.

The co-primary safety outcome measures were Cryoablation Procedure Events (CPEs) in cryoablated subjects and Major Atrial Fibrillation Events (MAFEs) in both groups. CPEs were device- or procedure-related serious adverse events.

Other safety assessments were made during the course of the STOP AF trial specific to pulmonary vein stenosis (PVS) and phrenic nerve injury.

Being tested
Arctic Front® Cryoablation Catheter, Flecainide or Sotalol or Propafenone
Keywords
Atrial Fibrillation
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® Cryoablation CatheterDevice

    Also called Arctic Front® Cardiac CryoAblation Catheter System, Artic Front®

    Experimental Subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci with the cryoablation catheter system.

  • Flecainide or Sotalol or PropafenoneDrug

    Also called Tambocor, Sotalol, Propafenone

    Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day

Study groups in NCT00523978
Study groupRoleWhat they receive
ExperimentalExperimentalExperimental subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci. If necessary, experimental subjects were allowed a previously failed Study Atrial Fibrillation Drug (AF Drug).
Receives: Device: Arctic Front® Cryoablation Catheter
ControlActive comparatorControl Subjects were treated with an AF Drug (flecainide, propafenone, or sotalol) that they had not previously failed.
Receives: Drug: Flecainide or Sotalol or Propafenone

What is being measured

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

  1. Acute Procedural Success (APS)

    Acute Procedural Success was defined as a demonstration of electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure. APS was decided at the end of the procedure the mean time was calculated for the time frame.

    Measured: 371.4 Minutes (Average)

  2. Freedom From Chronic Treatment Failure (CTF)

    Subjects that did not have or were free of CTF. CTF was defined as the occurence of an Atrial Fibrillation (AF) intervention, use of non-study AF drug therapy, or the occurence of detectable AF which is is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.

    Measured: 12 month follow up period

  3. Treatment Success

    Treatment Success was defined as Acute Procedure Success (APS) and freedom from Chronic Treatment Failure (CTF) for Experimental Subjects, and freedom from CTF for Control Subjects. Under this pre-specified definition of Treatment Success, Experimental Subjects must have had APS and remained free of CTF during the 12-month follow-up duration, while Control Subjects must have remained free of CTF during the 12-month follow-up duration.

    Measured: 12 months

  4. Freedom From Major Atrial Fibrillation Events (MAFEs)

    Subjects that did not have or were free of MAFEs. MAFEs were serious adverse events categorized as cardiovascular death, myocardial infarction, stroke, or hospitalization for AF recurrence/ablation, flutter ablation, embolic events, heart failure, hemorrhage or anti-arrhythmic drug treatment.

    Measured: 12 Months

  5. Cryoablation Procedure Events (CPEs)

    Subjects that had CPEs. CPEs were device- or procedure-related serious adverse events (SAE) categorized as access site complications, cardiac damage, pulmonary vein (PV) stenosis, embolic complications, arrhythmias, unresolved phrenic nerve palsy and death.

    Measured: To end of ablation procedure

Timeline

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

  1. First posted3 Sep 2007 (estimated)
  2. Study startOct 2006
  3. Primary completionAug 2010
  4. Study completionJul 2011

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00523978
Sponsor's protocol ID
PS-023
Acronym
Stop-AF
Status last verified
Sep 2018
First submitted
31 Aug 2007
Last updated
16 Oct 2018
Data monitoring committee
No

Publications

  • Packer DL, Kowal RC, Wheelan KR, Irwin JM, Champagne J, Guerra PG, Dubuc M, Reddy V, Nelson L, Holcomb RG, Lehmann JW, Ruskin JN; STOP AF Cryoablation Investigators. Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol. 2013 Apr 23;61(16):1713-23. doi: 10.1016/j.jacc.2012.11.064. Epub 2013 Mar 21.

    PubMed 23500312

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Arctic Front® Cryoablation Catheter and Flecainide or Sotalol or Propafenone in people with Paroxysmal Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 26 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 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2012). 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?

Acute Procedural Success (APS) (time frame: 371.4 Minutes (Average)). The study lists 5 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 NCT00523978, 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 16 Oct 2018.

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