The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - Nested Registry 3/Valve-in-Valve

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.

Inclusion Criteria:

1. 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.

Exclusion Criteria:

1. Bioprosthetic valve labeled external diameter < 21mm.

2. Surgical or transcatheter valve in another position on the same side of the heart
(mitral and tricuspid rings are not an exclusion).

3. Infectious endocarditis within 6 months.

4. Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.