STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation

Completed · Not applicable

Conditions studied: Atrial Fibrillation, Atrial Fibrillation New Onset

In brief

To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the subjects be drug refractory.

Key facts

Study ID

NCT03118518

Run by

Medtronic Cardiac Ablation Solutions

People needed

225

Starts

2017-06-23

Expected to finish

2020-06-25

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of symptomatic paroxysmal AF with the following documentation: (1) physician's note indicating recurrent self- terminating AF or paroxysmal AF; and (2) any ECG documented AF within 6 months prior to enrollment.
• Age 18-80

You may not qualify if…

• History of AF treatment with class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days with the intention to convert an AF episode are allowed.
• Prior persistent AF (cardioversion after 48 hours or continuous AF that is sustained >7 days)
• Left atrial diameter greater than 5.0 cm
• Prior left atrial ablation or left atrial surgical procedure
• 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)
• Body mass index (BMI) >35 kg/m2
• Presence of any pulmonary vein stents
• Known presence of any pre-existing pulmonary vein stenosis
• Pre-existing hemidiaphragmatic paralysis
• Presence of any cardiac valve prosthesis
• Moderate or severe mitral valve regurgitation or stenosis
• Any cardiac surgery, myocardial infarction, percutaneous coronary intervention/ percutaneous transluminal coronary angioplasty or coronary artery stenting which occurred during the 90 day interval preceding the date the subject signed the Informed Consent Form
• Unstable angina
• New York Heart Association (NYHA) class III or IV congestive heart failure and/or known left ventricular ejection fraction (LVEF) less than 45%
• Diagnosis of primary pulmonary hypertension
• Rheumatic heart disease
• Thrombocytosis, thrombocytopenia
• Contraindication to anticoagulation therapy
• Active systemic infection
• Hypertrophic cardiomyopathy
• Cryoglobulinemia
• Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, obstructive sleep apnea, and acute alcohol toxicity.
• Any cerebral ischemic event (strokes or transient ischemic attacks) which occurred during the 180 day interval preceding the date the subject signed the Informed Consent Form, or any known unresolved complications from previous stroke/transient ischemic attack
• Existing thrombus
• Pregnancy

Where it is running

• Grandview Medical Center — Birmingham, Alabama, United States
• Alaska Heart Institute — Anchorage, Alaska, United States
• Hoag Hospital Newport Beach — Newport Beach, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Tallahassee Research Institute Inc — Tallahassee, Florida, United States
• BayCare Medical Group Cardiology — Tampa, Florida, United States
• Wellstar Research Institute — Marietta, Georgia, United States
• Krannert Institute of Cardiology — Indianapolis, Indiana, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• Our Lady of the Lake Office of Research — Baton Rouge, Louisiana, United States
• Southcoast Health System — New Bedford, Massachusetts, United States
• University of Michigan Health System - University Hospital — Ann Arbor, Michigan, United States
• Spectrum Health Hospitals — Grand Rapids, Michigan, United States
• HealthEast Saint Josephs Hospital — Saint Paul, Minnesota, United States
• Bryan Heart — Lincoln, Nebraska, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Integris Baptist Medical Center, Inc. — Oklahoma City, Oklahoma, United States
• Providence Saint Vincent Medical Center — Portland, Oregon, United States
• Lehigh Valley Health — Allentown, Pennsylvania, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Aurora Cardiovascular Services — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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