Continued Access Protocol

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.

Key facts

Study ID

NCT00889681

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

81

Starts

2009-03-01

Expected to finish

2013-10-01

Last updated by the study team

2018-09-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must fulfill ALL of the following criteria:
• Documented PAF:
• diagnosis of paroxysmal atrial fibrillation (PAF) (Section 9.1.18, General Protocol Terminology), AND
• 2 or more episodes of AF during the 3 months preceding the Consent Date, at least 1 of which must be documented with a tracing
• 18 and 75 years of age
• Failure for the treatment of AF (effectiveness or intolerance) of one or more of the following drugs indicated in the treatment of PAF: flecainide, propafenone, sotalol or dofetilide.

You may not qualify if…

• ANY of the following is regarded as a criterion for excluding a subject from the study:
• 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
• 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

Where it is running

• Banner Good Samaritan — Phoenix, Arizona, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Stanford Hospital & Clinical — Stanford, California, United States
• Bay Heart Group — Tampa, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Baylor Heart & Vascular Hospital — Dallas, Texas, United States
• Inova Research Center — Falls Church, Virginia, United States
• Virginia Commonwealth University Health System — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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