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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
291
Navistar ThermoCool catheter
University of Alabama, Birmingham
Birmingham, Alabama, United States
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.
Time frame: During the procedure
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.
Time frame: 7 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 13 more locations