Durability of Pulmonary Vein Isolation Following Cryoablation for Treatment of Paroxysmal Atrial Fibrillation (SUPIR)

Medtronic

Status and phase

Completed

Phase 4

Conditions

Paroxysmal Atrial Fibrillation

Treatments

Device: Arctic Front Advance Cardiac CryoAblation system

Study type

Interventional

Funder types

Industry

Identifiers

NCT01645917

SUPIR001

Details and patient eligibility

About

The purpose of the study is to determine the permanency of PV isolation with the Arctic Front Advance cryoablation system in paroxysmal AF patients. It will also provide data on acute procedural outcomes and measures as well as clinical AF recurrence in these patients approximately 3 months post-ablation.

Full description

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. It is estimated that more than 7 million people worldwide have the disease. Over the past decade, catheter ablation has become an accepted treatment for patients with AF. Ablation strategies that target the pulmonary vein are considered the cornerstone for treatment. The innovative Arctic Front cryoballoon is used for the treatment of drug refractory recurrent symptomatic paroxysmal AF (PAF). The system was designed to overcome many of the challenges of point-by-point catheter ablation by providing an anatomical approach for pulmonary vein isolation (PVI), creating long contiguous circumferential lesions surrounding the pulmonary vein. The cryoballoon system has a low risk of complications and proven efficacy in treating PAF.

AF recurrence rates have been reported up to 30% after initial ablation with PVI technologies including point-by-point RF catheter ablation. Arrhythmia recurrence can be caused by non-contiguous ablation lines that allow conduction gaps. Arctic Front Advance™ Cardiac CryoAblation Catheter (Arctic Front Advance), the second-generation cryoballoon which has recently been introduced following clearance by regulatory agencies in both the US and EU, is positioned to address this challenge with PVI technologies. The new catheter features the EvenCool™ Cryo Technology, which optimizes how the refrigerant is distributed inside the balloon, providing more uniform, distal cooling around the circumference of the balloon. The purpose of this study is to examine the rate of electrical PV isolation with the next generation system .

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is at least 18 years old
Subject has been diagnosed with recurrent, symptomatic paroxysmal atrial fibrillation, documented as per institutional practice
Left atrial diameter is no larger than 5.5cm
Subject has failed one or more anti-arrhythmic drugs
Subject is indicated for a pulmonary vein ablation using Arctic Front Advance
Subject (or subject's legally authorized representative) is able and willing to give informed consent

Exclusion criteria

Subject has persistent (>7 days) or permanent AF
Subject has a left atrial thrombus detected on TEE
Subject has had a prior left atrial ablation
Subject has an intracardiac thrombus
Subject is contraindicated for EP study
Subject is unable to tolerate heparin or oral anti-coagulation
Subject has a cardiac valve prosthesis
Subject has advanced structural heart disease, congenital heart disease (repaired or not), left ventricular ejection fraction (LVEF) <45%, coronary artery bypass graft within 3 months of the procedure
Subject has presence of any pulmonary vein stents
Subject has presence of any pre-existing pulmonary vein stenosis
Subject has had a cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date
Subject is a woman known to be pregnant, as documented in medical record
Subject is unwilling or unable to comply fully with study procedures and follow-up