Safety and Efficacy of CryoCor™ Cryoablation for PAF

Boston Scientific

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Cardiac CryoCor Cryoablation System; Drug: Medical management

Study type: Interventional

Funder types: Industry

Identifiers

NCT00231296

GL-AF-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 174 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 3 episodes of PAF within 6 months
• Refractory to at least one drug
• Therapeutic anticoagulation
• Signed informed consent

Exclusion criteria

• Persistent AF
• Structural heart disease
• Prior ablation
• Contraindication present

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

Treatment with CryoCor Cryoablation System

Active Comparator group

Description:

Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF.

Treatment:

Device: Cardiac CryoCor Cryoablation System

Treatment with standard medical therapy

Active Comparator group

Description:

Intervention includes treatment with ant-arrhythmic medications alone.

Treatment:

Drug: Medical management