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

Study Overview
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Brief Summary
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To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.

Detailed Description
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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.

Official Title
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Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Patients With a Failing Aortic Bioprosthetic Valve

Conditions
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Aortic Stenosis, Cardiomyopathy, Hypertrophic

Intervention / Treatment
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* Device: Edwards SAPIEN XT transcatheter valve, Model 9300TFX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater. The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient. 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. Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%. Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position. Exclusion Criteria: Bioprosthetic valve labeled external diameter < 21mm. Surgical or transcatheter valve in another position on the same side of the heart (mitral and tricuspid rings are not an exclusion). Infectious endocarditis within 6 months. Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Failing surgical valve<br>Patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve. | Device: Edwards SAPIEN XT transcatheter valve, Model 9300TFX<br>* Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.<br>* Other names: TAVI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite) | The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak | 30-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Mortality From Any Cause | Cardiovascular cause is also included | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SAVR, SAPIEN XT, Partner II, cardiovascular disease, heart disease, aortic disease, TAVR, failing surgical valve, failing valve, failing bioprosthetic valve