Viewing Study NCT00113178



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Last Modification Date: 2024-10-26 @ 9:12 AM
Study NCT ID: NCT00113178
Status: COMPLETED
Last Update Posted: 2011-02-24
First Post: 2005-06-06

Brief Title: Safety and Efficacy of the CryoCor Cardiac Cryoablation System for the Treatment of Atrial Flutter
Sponsor: Boston Scientific Corporation
Organization: Boston Scientific Corporation

Study Overview

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
Status: COMPLETED
Status Verified Date: 2011-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None