aortavalve replacement - disease of the aortavalve
Conditions
Interventions
None listed
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is a candidate for surgical aortic valve replacement per current guidelines and is intended to be implanted with a St. Jude Medical Trifecta GT valve. 2. Subject is of legal age in the country where the subject is enrolled. 3. Subject must be willing and able to provide written informed consent to participate in this study. 4. Subject must be willing and able to comply with all follow-up requirements.
Exclusion criteria
Exclusion criteria: 1. Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the Trifecta GT valve implantation surgery. 2. Subject has contraindication for cardiac surgery. 3. Subject is pregnant. Pregnancy will be assessed by the subject informing the physicians. 4. Subject has active endocarditis (subjects who have previously experienced endocarditis must have two documented negative blood culture results while off antibiotic therapy prior to the valve implantation surgery). 5. Subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery. 6. Subject is undergoing renal dialysis. 7. Subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years. 8. Subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery. 9. Subject has a left ventricular ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from surgical valve replacement or transcatheter valve-in-valve implantation at 5 years post implant. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Freedom from all-cause mortality at 5 years post implant * Freedom from valve related mortality at 5 years post implant * Freedom from Structural Valve Deterioration (SVD) at 5 years post implant * Freedom from surgical valve replacement or transcatheter valve Implantation due to SVD at 5 years post implant * Valve hemodynamic performance (e.g. left ventricular ejection fraction, mean and peak gradients, aortic insufficiency and effective orifice area via any available/performed echocardiograms) at pre-discharge, 6 months, 3 years and 5 years post implant. | — |
Countries
Netherlands
Outcome results
None listed