Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Edwards Lifesciences
A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency. This is a PARTNER II nested registry.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA \< 0.5 cm2/m2. Qualifying echo must be within 60 days of the date of the procedure.
2. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
3. The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
4. The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
5. Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.
6. Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position.
