NCT00231296

Safety and Efficacy of CryoCor™ Cryoablation for PAF

A Clinical Study to Evaluate the Safety and Efficacy of the CryoCor(TM)Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF

Detailed description

The purpose of this prospective, randomized multi-center clinical study is to establish the benefits of the CryoCor(TM) Cardiac Cryoablation System for treating symptomatic paroxysmal atrial fibrillation (PAF) in comparison to treatment with anti-arrhythmic medications alone. This study also evaluates the safety profile of the CryoCor(TM) Cardiac Cryoablation System when used in this same setting.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Cardiac CryoCor Cryoablation System	Treatment with CryoCor Cardiac Cryoablation system
DRUG	Medical management	Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications

Timeline

• Start date: 2004-11-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2005-10-04
• Last updated: 2017-05-04

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated device study