IRB Study Number 26-266
Status Recruiting
Institute Heart and Vascular Institute
Description
You would be invited to participate in a research study if you are undergoing treatment with the FDA-approved "WiSE System" as part of your normal care for your heart failure, as decided by you and your doctor. The WiSE system is a cardiac resynchronization therapy device that helps the heartbeat in a more coordinated way so it can pump blood more effectively.
As part of this study, your health information would be collected by the study team at a baseline visit, and visits following your implant procedures. These visits would occur at 1 month, 6 months, 12 months, and 2, 3, 4, and 5 years thereafter. The information would include collection of Demographic data (such as age and gender), information from your medical records such as medical history, details about the surgery to implant the device, any problems, complications or side effects from the implant procedure, and quality of life questionnaires. Each questionnaire would take approximately 10 minutes to complete.
Your participation in the research study would be approximately 7 years from when the first patient is enrolled until the last patient reaches the 5-year follow-up visit. The study team would collect your health data for 5 years following your implant procedure.
Inclusion Criteria
• Patient or legally authorized representative can provide written authorization and/or consent per institution requirements.
• Patient is intended to receive a WiSE System and passed the acoustic window screening
• Patient who is, or will be, accessible for follow-up.
Exclusion Criteria
• Patient is enrolled in a concurrent drug and/or device study that may confound the Registry results.
• Participation is excluded by local law.
