NCT00113178
Completed
Phase 3
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
ConditionsAtrial Flutter
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Atrial Flutter
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 160
- Primary Endpoint
- Acute efficacy
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Symptomatic atrial flutter
Exclusion Criteria
- •Prior ablation
- •Contraindication to intervention
- •Poor general health
Outcomes
Primary Outcomes
Acute efficacy
Acute safety
Secondary Outcomes
- Long-term efficacy
- Long-term safety
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