The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices. It will also validate the device survival information given in Boston Scientific's Product Performance Report by comparing the pulse generator (PG) survival probability in the study to that presented in the Product Performance Reports (PPR)
Study Type
OBSERVATIONAL
Enrollment
1,600
Alabama cardiovascular group
Birmingham, Alabama, United States
Birmingham Heart Clinic, P.C.
Birmingham, Alabama, United States
Phoenix Heart, PLLC
Glendale, Arizona, United States
Pima Heart Physicians PC
Tucson, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Determine the rate and cause of all-cause device replacements of Boston Scientific's market-released ICD and CRT-D devices at 5 years post-implantation.
Time frame: 5 years
Evaluate the battery survival of Boston Scientific's market-released ICD and CRT-D devices at 5 years post-implantation.
Battery survival is defined as freedom from surgical replacement of the device due to battery depletion.
Time frame: 5 years
Determine the rate and cause of all-cause device replacement of Boston Scientific's market-released ICD and CRT-D devices 1, 2, 3 and 4 years post-implantation.
Time frame: 1, 2, 3, and 4 years
Evaluate battery survival of Boston Scientific's market-released ICD and CRT-D devices at 1, 2, 3 and 4 years post-implantation.
Time frame: 1, 2, 3, and 4 years
Evaluate the device survival of Boston Scientific's market released ICD and CRT-D pulse generators at 5 years post-implantation; and compare it to the survival probability presented in the Product Performance Report (PPR).
Time frame: 5 years
Evaluate potential predictors of device battery longevity at 5 years post-implantation.
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mercy Clinic Cardiology Physician Plaza
Rogers, Arkansas, United States
VA Loma Linda Healthcare System
Loma Linda, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Bradenton Cardiology Center
Bradenton, Florida, United States
Jackson Memorial Hospital, JHS Office of Research
Miami, Florida, United States
...and 70 more locations