STOP Persistent AF

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT03012841

Run by

Medtronic Cardiac Ablation Solutions

People needed

186

Starts

2017-03-02

Expected to finish

2019-08-13

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• 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

Where it is running

• Banner-University Medical Center Phoenix — Phoenix, Arizona, United States
• Colorado Heart and Vascular — Lakewood, Colorado, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Cardiac Arrhythmia Service — Boca Raton, Florida, United States
• Saint Vincent's Medical Center — Jacksonville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• NorthShore University Health System — Evanston, Illinois, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• St. Luke's Health System — Kansas City, Missouri, United States
• Englewood Hospital & Medical Center — Englewood, New Jersey, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Northwell Health (Lenox Hill Hospital and Staten Island University Hospital) — New York, New York, United States
• Asheville Cardiology Associates — Asheville, North Carolina, United States
• Doylestown Health Cardiology — Doylestown, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor Research Institute — Dallas, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Swedish Medical Center — Seattle, Washington, United States
• Victoria Cardiac Arrhythmia Trials — Victoria, British Columbia, Canada
• London Health Sciences Centre — London, Ontario, Canada
• Institut Universitaire de Cardiologie et de Pneumologie de Québec — Québec, Canada
• Tokyo Medical and Dental University — Bunkyō, Tokyo, Japan
• Jikei University Hospital — Tokyo, Japan
• Yokohama City Minato Red Cross Hospital — Yokohama, Japan

Full record on ClinicalTrials.gov

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