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Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00318565
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : March 2, 2010
Last Update Posted : March 5, 2012
Information provided by (Responsible Party):
Biosense Webster, Inc.

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).

Condition or disease Intervention/treatment Phase
Atrial Flutter Device: RF energy delivery for treatment of Typical Atrial flutter Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Navistar Thermocool Evaluation of the Catheter With the Stockert 70 Radiofrequency Generator for Endocardial Ablation in Patients With Typical Atrial Flutter
Study Start Date : January 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Experimental: Navistar ThermoCool Catheter Device: RF energy delivery for treatment of Typical Atrial flutter
Navistar ThermoCool catheter
Other Name: Therapeutic Catheters

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Two symptomatic episodes of typical atrial flutter (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFL occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFL tachyarrhythmia, including atrial fibrillation.
  • At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device within 6 months prior to enrollment.
  • 18 years of age or older
  • Informed consent

Exclusion Criteria:

  • Intracardiac thrombus
  • Uncontrolled heart failure, or New York Heart Association (NYHA) class III or IV heart failure
  • Women who are pregnant
  • Cardiac surgery (ventriculotomy or atriotomy) within the past two months
  • Intra-atrial thrombus, tumor, or other abnormality that precludes catheter introduction and placement
  • Unstable angina or acute myocardial infarction within 3 months
  • Awaiting cardiac transplantation
  • Heart disease in which corrective surgery is anticipated within 6 months
  • Presence of condition that precludes appropriate vascular access
  • Enrolled in any investigational device exemption (IDE) investigating study for a device or drug
  • High risk for non-compliance with the protocol (e.g., inaccessible for follow-up by the investigator or patient's physician)
  • Radio frequency (RF) ablation for typical atrial flutter within the past 2 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00318565

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Sponsors and Collaborators
Biosense Webster, Inc.
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Principal Investigator: Warren Jackman, M.D. University of Oklahoma
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Responsible Party: Biosense Webster, Inc. Identifier: NCT00318565    
Other Study ID Numbers: BWI30031
First Posted: April 27, 2006    Key Record Dates
Results First Posted: March 2, 2010
Last Update Posted: March 5, 2012
Last Verified: March 2012
Keywords provided by Biosense Webster, Inc.:
Heart Disease
Atrial Flutter
Typical Atrial Flutter
Additional relevant MeSH terms:
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Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes