Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter
Atrial Flutter
About this trial
This is an interventional treatment trial for Atrial Flutter focused on measuring Heart Disease, Atrial Flutter, Typical Atrial Flutter
Eligibility Criteria
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
Sites / Locations
- University of Alabama, Birmingham
- Arizona Arrhythmia Consultants
- Good Samaritan Hospital
- Pacific Heart Institute
- University of Florida
- Memorial Regional Hospital
- Florida Hospital
- University of Chicago
- The Care Group LLC, St. Vincent Hospital and Health Care Center, Inc.
- Central Baptist Hospital
- Maine Medical Center
- University of Maryland
- Massachusetts General Hospital
- St. John Hospital and Medical Center
- Park Nicollet Institute
- Duke University Medical Center
- University of Oklahoma, Health Sciences Center
- University of Pennsylvania
- Medical University of South Carolina
- Texas Heart Institute
- University of Vermont, College of Medicine
- INOVA Research Center
- Virginia Commonwealth University
Arms of the Study
Arm 1
Experimental
Navistar ThermoCool Catheter