Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter
Primary Purpose
Atrial Flutter
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Catheter-based cardiac cryoablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter focused on measuring atrial flutter, cryoablation
Eligibility Criteria
Inclusion Criteria: Symptomatic atrial flutter Exclusion Criteria: Prior ablation Contraindication to intervention Poor general health
Sites / Locations
Outcomes
Primary Outcome Measures
Acute efficacy
Acute safety
Secondary Outcome Measures
Long-term efficacy
Long-term safety
Full Information
NCT ID
NCT00113178
First Posted
June 6, 2005
Last Updated
February 23, 2011
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00113178
Brief Title
Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
Keywords
atrial flutter, cryoablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Catheter-based cardiac cryoablation
Primary Outcome Measure Information:
Title
Acute efficacy
Title
Acute safety
Secondary Outcome Measure Information:
Title
Long-term efficacy
Title
Long-term safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic atrial flutter
Exclusion Criteria:
Prior ablation
Contraindication to intervention
Poor general health
12. IPD Sharing Statement
Links:
URL
http://www.cryocor.com/
Description
Related Info
Learn more about this trial
Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter
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