Symptomatic Severe Aortic Stenosis
Conditions
Keywords
SAPIEN 3, Transfemoral, Transapical, Transaortic, NovaFlex, TAVI, Aortic Stenosis, THV, Aortic Valve, Transcatheter Heart Valve, TAVR
Brief summary
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.
Detailed description
This study design consists of PIIS3i cohort. The PIIS3i cohort is a single arm non-randomized, historical-controlled study. Patients recruited to the treatment arm will receive an Edwards SAPIEN 3 THV with either transfemoral, transapical or transaortic delivery access. To ensure that patients are of intermediate risk, an STS score of 4 - 8% has been selected.
Interventions
DEVICETAVR
Implantation of the SAPIEN 3
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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 is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater. 3. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient. 4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. 5. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.
Exclusion criteria
1. Heart team assessment of inoperability (including examining cardiac surgeon). 2. Complex coronary artery disease 1. Unprotected left main coronary artery 2. Syntax score \> 32 (in the absence of prior revascularization) 3. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of screening evaluation. 4. Need for emergency surgery for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days | 30 Days |
Countries
United States
Participant flow
Recruitment details
Subjects were screened and enrolled at 51 sites in the US
Pre-assignment details
The As-Treated population was 1074 The Valve-Implanted population was 1069
Participants by arm
| Arm | Count |
|---|---|
| PIIS3i - SAPIEN 3 PIIS3i - SAPIEN 3 is Operable Group
TAVR: Implantation of the SAPIEN 3 | 1,074 |
| Total | 1,074 |
Baseline characteristics
| Characteristic | PIIS3i - SAPIEN 3 |
|---|---|
| Age, Continuous | 81.9 years STANDARD_DEVIATION 6.6 |
| NYHA Classification III/IV | 780 Participants |
| Sex: Female, Male Female | 412 Participants |
| Sex: Female, Male Male | 662 Participants |
| STS Score | 5.3 units on a scale STANDARD_DEVIATION 1.29 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 75 / 1,069 |
| other Total, other adverse events | 861 / 1,069 |
| serious Total, serious adverse events | 592 / 1,069 |
Outcome results
Primary
Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate
Time frame: 1 year
Population: AI as a factor in this value; only 964/1069 patients had ECHO data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PIIS3i - SAPIEN 3 | Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate | 125 Participants |
Secondary
Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PIIS3i - SAPIEN 3 | Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days | 196 Participants |