The purpose of the BIO-AffectDX Study is to prospectively evaluate improvement from baseline in heart failure subjects with atrial fibrillation (AF) implanted with a two-lead CRT-DX system, with emphasis on a comparison of patient outcomes between AF subtypes.
There is a need for more evidence about the benefits of Cardiac Resynchronization Therapy (CRT) in a patient population with heart failure and atrial fibrillation. The BIO-AffectDX Study will gather information about adults with heart failure and atrial fibrillation who are treated with a CRT-DX device from many locations across the United States. The BIO-AffectDX Study will look at the results of treatment in participants with the primary goal to evaluate the improvement in overall health prior to device implant through 12 months. Overall health will be measured by your study doctor for AF improvement, physical fitness, and general quality of life.
Study Type
OBSERVATIONAL
Enrollment
13
Evaluation of overall health, including heart failure and atrial fibrillation improvement, changes in physical fitness, and general quality of life.
University of California San Diego - La Jolla
La Jolla, California, United States
Change in Clinical Composite Score from baseline
Time frame: 12 months
Rate of composite all-cause death and heart failure
Time frame: 12 months
Change in quality of life questionnaires from baseline for all patients and by atrial fibrillation sub-type
Time frame: 6 and 12 months
Change in New York Heart Association class from baseline for all patients and by atrial fibrillation sub-type
Time frame: 6 and 12 months
Change in six-minute walk distance from baseline for all patients and by atrial fibrillation sub-type
Time frame: 6 and 12 months
Change in atrial fibrillation burden from baseline for all patients and by atrial fibrillation sub-type
Time frame: 6 and 12 months
Change in Clinical Composite Score from baseline
Time frame: 6 months
Rate of major complications
Time frame: 12 months
Rate of conversion to sinus rhythm
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cardiology Associates Medical Group
Ventura, California, United States
Orlando Health Heart Institute
Orlando, Florida, United States
AdventHealth Tampa
Tampa, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky - Gill Heart and Vascular Institute
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
...and 13 more locations