NCT01645917

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

SUstained PV Isolation With aRctic Front Advance

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 .

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Arctic Front Advance Cardiac CryoAblation system	Standard of care ablation for indicated paroxysmal AF patients with Medtronic's Arctic Front Advance Cardiac CryoAblation system

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-07-01
• Completion: 2013-11-01
• First posted: 2012-07-20
• Last updated: 2018-09-19

Locations

1 site across 1 country: Czechia