Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter

Boston Scientific

Status and phase: Completed; Phase 3

Conditions: Atrial Flutter

Treatments: Device: Catheter-based cardiac cryoablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00113178

GL-AFL-02

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of right atrial intra-cardiac lesions created by transvenous catheter cryoablation in patients with atrial flutter.

Full description

Catheter ablation of arrhythmias has become an accepted alternative to pharmacologic therapy. Cryoablation is a newer alternative to radiofrequency ablations. This study expands the prior pilot experience with the CryoCor™ Cardiac Cryoablation System to a larger cohort of patients with atrial flutter.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic atrial flutter

Exclusion criteria

• Prior ablation
• Contraindication to intervention
• Poor general health

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)