Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter
This study has been completed.
Information provided by:
Boston Scientific Corporation
First received: June 6, 2005
Last updated: February 23, 2011
Last verified: February 2011
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.
Device: Catheter-based cardiac cryoablation
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Acute efficacy
- Acute safety
Secondary Outcome Measures:
- Long-term efficacy
- Long-term safety
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
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.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Symptomatic atrial flutter
- Prior ablation
- Contraindication to intervention
- Poor general health
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History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 6, 2005
||February 23, 2011
||United States: Food and Drug Administration
Keywords provided by Boston Scientific Corporation:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 31, 2015