Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter
- Conditions
- Atrial Flutter
- Interventions
- Device: RF energy delivery for treatment of Typical Atrial flutter
- Registration Number
- NCT00318565
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 291
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Navistar ThermoCool Catheter RF energy delivery for treatment of Typical Atrial flutter -
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Complete Bidirectional Conduction Block. 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. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Vermont, College of Medicine
🇺🇸Burlington, Vermont, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, 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, 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
University of Maryland
🇺🇸Baltimore, Maryland, United States
INOVA Research Center
🇺🇸Falls Church, Virginia, United States
University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
University of Florida
🇺🇸Gainsville, Florida, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Park Nicollet Institute
🇺🇸Minneapolis, Minnesota, United States
University of Oklahoma, Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States