This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.
The TRUE HD Study is aimed at collecting real-world data on the use of the Rhythmia mapping system and the IntellaMap Orion mapping catheter in patients indicated for ablation procedure with use of a 3D Mapping system. The study will collect specific information on management of ablation procedures with the commercial system including but not limited to acute procedural success, type and proportion of arrhythmias mapped/treated, and how mapping system is used overall. Usage data may be used for the planning of future clinical trials.
Study Type
OBSERVATIONAL
Enrollment
577
A 3-D Cardiac Mapping system
A diagnostic basket mapping catheter
Acute Procedural Success
Primary endpoint is the acute procedural success for the primary arrhythmia in the whole cohort of ablation procedures. A procedure will be defined successful if all the following conditions will occur during the case: 1) ability to map, 2) completion of the necessary ablation applications, 3) primary arrhythmia termination (when applicable), and 4) validation of ablation through appropriate technique(s).
Time frame: At the end of the index procedure (Day 0)
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Hoag Memorial Hospital
Orange, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
University of Chicago Hospital
Chicago, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
University of Michigan Hospitals
Ann Arbor, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Maimonidies Hospital
New York, New York, United States
Strong Memorial Hospital of the University of Rochester
Rochester, New York, United States
...and 18 more locations