This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.
In this study, patients are randomized to DDD mode, AAIsafeR mode, or AAIsafeR mode plus atrial arrhythmia preventive algorithms. The atrial arrhythmia (AA) burden serves as the primary measure of effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
Atrial arrhythmia burden
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Baywood Heart Hospital
Mesa, Arizona, United States
Brentwood Biomedical Research Institute
Los Angeles, California, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Passaic Beth Israel Regional Medical Center
Passaic, New Jersey, United States
NorthEast Medical Center
Concord, North Carolina, United States
Hillcrest Medical Center
Tulsa, Oklahoma, United States
Lancaster Regional Medical Center
Lancaster, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
...and 42 more locations