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

Phase 3

Completed

• Conditions: Atrial Flutter

• Registration Number: NCT00113178
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2004-01
• Study Completion: 2005-06
• Study First Submitted: 2005-06-06
• Study First Submitted QC: 2005-06-06
• Study First Posted: 2005-06-07
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-23
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Symptomatic atrial flutter

Exclusion Criteria

• Prior ablation
• Contraindication to intervention
• Poor general health

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acute efficacy
Acute safety

Secondary Outcome Measures

Name	Time	Method
Long-term efficacy
Long-term safety