Aortic Stenosis, Cardiomyopathy, Hypertrophic
Conditions
Keywords
SAPIEN XT, Partner II, cardiovascular disease, heart disease, aortic disease, SAVR, TAVR, failing surgical valve, failing valve, failing bioprosthetic valve
Brief summary
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
Detailed description
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.
Interventions
DEVICEEdwards SAPIEN XT transcatheter valve, Model 9300TFX
Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite) | 30-day | The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Mortality From Any Cause | 30 Days | Cardiovascular cause is also included |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Edwards SAPIEN XT THV in Patients With Failing SAVR Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.
Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems. | 197 |
| Total | 197 |
Baseline characteristics
| Characteristic | Edwards SAPIEN XT THV in Patients With Failing SAVR |
|---|---|
| Age, Continuous | 78.5 Years STANDARD_DEVIATION 11 |
| NYHA III/IV | 188 Participants |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 119 Participants |
| STS Score | 9.7 units on a scale STANDARD_DEVIATION 5.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 195 |
| other Total, other adverse events | 142 / 195 |
| serious Total, serious adverse events | 109 / 195 |
Outcome results
Primary
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
Time frame: 30-day
Population: Twenty-nine patients had missing echocardiography data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards SAPIEN XT THV in Patients With Failing SAVR | Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite) | 28 Participants |
Secondary
Number of Participants With Mortality From Any Cause
Cardiovascular cause is also included
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards SAPIEN XT THV in Patients With Failing SAVR | Number of Participants With Mortality From Any Cause | 8 Participants |