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

Completed · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation (PAF)

In brief

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.

Key facts

Study ID

NCT01456949

Run by

Medtronic Cardiac Ablation Solutions

People needed

402

Starts

2012-06-26

Expected to finish

2017-11-30

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…

• 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.

You may not qualify if…

• 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
• Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.

Where it is running

• Alaska Heart Institute — Anchorage, Alaska, United States
• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• Good Samaritan Hospital — San Jose, California, United States
• Colorado Heart and Vascular — Denver, Colorado, United States
• Daytona Heart Group — Daytona Beach, Florida, United States
• Broward General Medical Center — Fort Lauderdale, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• WellStar Kennestone Hospital — Marietta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Memorial Advanced Cardiovascular Institute — South Bend, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Metropolitan Cardiology Consultants PA — Coon Rapids, Minnesota, United States
• St. Mary's Hospital - Mayo Clinic — Rochester, Minnesota, United States
• HealthEast St. Joseph's Hospital — Saint Paul, Minnesota, United States
• Bryan LGH — Lincoln, Nebraska, United States
• Asheville Cardiology Associate PA — Asheville, North Carolina, United States
• Bethesda North Hospital l TriHealth Hatton Institute — Cincinnati, Ohio, United States
• Oklahoma Heart Institute — Tulsa, Oklahoma, United States
• Capital Cardiovascular Associates — Camp Hill, Pennsylvania, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Doylestown Cardiology Associates — Doylestown, Pennsylvania, United States
• Lancaster Heart & Stroke — Lancaster, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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