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| Sponsored by: |
CryoCor |
| Information provided by: | CryoCor |
| ClinicalTrials.gov Identifier: | NCT00113178 |
Purpose
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.
| Condition | Intervention | Phase |
|
Atrial Flutter |
Device: Catheter-based cardiac cryoablation |
Phase III |
| Genetics Home Reference related topics: | Brugada syndrome short QT syndrome |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | June 2005 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
Related Info
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| Study ID Numbers: | GL-AFL-02 |
| First Received: | June 6, 2005 |
| Last Updated: | January 31, 2006 |
| ClinicalTrials.gov Identifier: | NCT00113178 |
| Health Authority: | United States: Food and Drug Administration |
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