Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter

Completed · Phase 4

Conditions studied: Atrial Flutter

In brief

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).

Key facts

Study ID

NCT00318565

Run by

Biosense Webster, Inc.

People needed

291

Starts

2006-01-01

Expected to finish

2008-02-01

Last updated by the study team

2012-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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