Symptomatic Severe Aortic Stenosis
Conditions
Keywords
SAPIEN 3, Transfemoral, Transapical, Transaortic, 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, severe aortic stenosis, and are in high risk.
Detailed description
This is a prospective, non-randomized, multi-center trial for patients undergoing aortic valve replacement with the Edwards SAPIEN 3 THV for severe aortic stenosis. Patient cohorts will include those inoperable and those considered as a high surgical risk (STS ≥8%). The study also includes NR7 patients (patients with a 20mm vessel size).
Interventions
DEVICETAVR Implantation of the THV Prosthesis
Patients with TAVR implantation
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. 6. STS \> 8
Exclusion criteria
1. Pre-existing mechanical or bioprosthetic valve in any position. 2. Active bacterial endocarditis within 6 months (180 days) of procedure. 3. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 4. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure. Implantation of a permanent pacemaker or ICD is not considered
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate | 30 Days | The composite rate of all-cause mortality, all stroke, and AI ≥ moderate for patients deemed as 'high risk' using the Edwards SAPIEN 3 transcatheter heart valve (THV). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Vascular Complications | 30 Days | The rate of major vascular complications at 30 days post implantation |
| Number of Participants With Aortic Insufficiency at 30 Days | 30 Days | The proportion of patients with aortic insufficiency ≥ moderate at 30 days. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SAPIEN 3™ Valve TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation | 583 |
| Total | 583 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 15 |
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | SAPIEN 3™ Valve |
|---|---|
| Age, Continuous | 82.6 years STANDARD_DEVIATION 8.1 |
| Coronary artery disease | 444 Participants |
| NYHA III/IV | 525 Participants |
| Sex: Female, Male Female | 245 Participants |
| Sex: Female, Male Male | 338 Participants |
| STS score | 8.6 units on a scale STANDARD_DEVIATION 3.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 13 / 583 |
| other Total, other adverse events | 397 / 583 |
| serious Total, serious adverse events | 232 / 583 |
Outcome results
Primary
The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate
The composite rate of all-cause mortality, all stroke, and AI ≥ moderate for patients deemed as 'high risk' using the Edwards SAPIEN 3 transcatheter heart valve (THV).
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SAPIEN 3™ Valve | The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate | 6.7 percentage of patients |
Secondary
Number of Participants With Aortic Insufficiency at 30 Days
The proportion of patients with aortic insufficiency ≥ moderate at 30 days.
Time frame: 30 Days
Population: Echo data was available only for 532 patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3™ Valve | Number of Participants With Aortic Insufficiency at 30 Days | 16 Participants |
Secondary
Number of Participants With Major Vascular Complications
The rate of major vascular complications at 30 days post implantation
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3™ Valve | Number of Participants With Major Vascular Complications | 29 Participants |