Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter

Atrial Flutter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318565
• Other study ID #: BWI30031
• Status: Completed
• Phase: Phase 4
• First received: April 25, 2006
• Last updated: March 1, 2012
• Start date: January 2006
• Est. completion date: February 2008

Study information

• Verified date: March 2012
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: February 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Device:
• RF energy delivery for treatment of Typical Atrial flutter
Navistar ThermoCool catheter

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Vermont, College of Medicine	Burlington	Vermont
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	INOVA Research Center	Falls Church	Virginia
United States	University of Florida	Gainsville	Florida
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Texas Heart Institute	Houston	Texas
United States	The Care Group LLC, St. Vincent Hospital and Health Care Center, Inc.	Indianapolis	Indiana
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Good Samaritan Hospital	Los Angeles	California
United States	Park Nicollet Institute	Minneapolis	Minnesota
United States	University of Oklahoma, Health Sciences Center	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Pacific Heart Institute	Santa Monica	California
United States	Arizona Arrhythmia Consultants	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Complete Bidirectional Conduction Block.	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.	During the procedure	No
Primary	Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.	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.	7 Days	Yes