Clinical Trial: Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Study to Evaluate the Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Cavo-Tricuspid Valve Isthmus-Dependent Atrial Flutter
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 Summary: 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.
Sponsor: Boston Scientific Corporation
Current Primary Outcome:
- Acute efficacy
- Acute safety
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Long-term efficacy
- Long-term safety
Original Secondary Outcome: Same as current
Information By: Boston Scientific Corporation
Dates:
Date Received: June 6, 2005
Date Started: January 2004
Date Completion:
Last Updated: February 23, 2011
Last Verified: February 2011
