Clinical Trial: Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Navistar Thermocool Evaluation of the Catheter With the Stockert 70 Radiofrequency Generator for Endocardial Ablation in Patients With Typical Atrial Flutter

Brief Summary: The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).

Detailed Summary: This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with symptomatic typical atrial flutter will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 221 evaluable subjects.
Sponsor: Biosense Webster, Inc.

Current Primary Outcome:

  • Percentage of Subjects With Complete Bidirectional Conduction Block. [ Time Frame: During the procedure ]
    Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.
  • Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure. [ Time Frame: 7 Days ]
    The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Biosense Webster, Inc.

Dates:
Date Received: April 25, 2006
Date Started: January 2006
Date Completion:
Last Updated: March 1, 2012
Last Verified: March 2012