US Patient Registry Protocol: ATS Open Pivot® Heart Valve Intra-Operative Assessment (OPIA) Revision B
| Purpose of trial: |
You are being asked to take part in this study because you will be having open heart surgery to place an artificial heart valve |
| Protocol Summary: |
Patients are being asked to give informed consent to be on a US registry because their heart valve(s) is being replaced. This study will collect data that contains date of birth, age, sex, height, weight, medical history, information about the surgical procedure, EKG results, laboratory results and echocardiogram results. There will be no additional testing or procedures, or visits to the hospital or clinic as a result of being in this study. Patients will be involved in this study for the length of their hospital stay at the time of the valve surgery. At any given point in the future, ATS Medical INC, or the surgeons office may evaluate the information to see if there are any trends or if any determinations can be made that may lead to improvements for future patient treatment. |
| Sponsoring Department: | Surgery - Division of Cardiothoracic Surgery |
| Sponsoring Company: | ATS Medical INC |
| Investigators: | Stephen R. Hazelrigg, MD, Jacqueline Quin, MD, Jeffrey Christy, MD, William Pyle, MD, Carl Arentzen, MD, William Stevens, MD, Theresa Boley, RN, MSN, APN/FNP |
| Number of other sites in trial: | SIU School of Medicine; Memorial Medical Center, St. John's Hospital |
| Basic Eligibility Criteria: | Need for valve surgery |
| Age: | 18 years of age or older |
| Health status: | |
| Number of visits required: | Patients will be involved in this study for the length of their hospital stay at the time of the valve surgery |
| SCHIRS Protocol Number: | |
| Contact Person: | Contact Person: Theresa Boley, RN, MSN, APN/FNP Contact Phone: 217-545-5000 Contact Email: tboley@siumed.edu |