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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
No publications provided
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 02, 2015