Aortic Valve Stenosis
Conditions
Keywords
Sapien XT Valve, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transapical, Transcatheter
Brief summary
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; study valve), the next generation Ascendra™ transapical delivery system, and crimper accessories.
Detailed description
Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and next generation Ascendra™ delivery components. Follow-up Intervals: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 month annually for 5 years.
Interventions
DEVICESAPIEN XT™ Transapical aortic valve replacement
Transcatheter aortic valve implantation via the transapical approach
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: 1. EuroSCORE of ≥ 15 % 2. Severe senile degenerative aortic valve stenosis 3. Symptomatic aortic valve stenosis 4. Informed consent 5. Compliance Exclusion: 1. Logistic Euroscore \> 40 % 2. Evidence of an acute myocardial infarction 3. Congenital unicuspid or congenital bicuspid valve/ non-calcified 4. Mixed aortic valve disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Deaths | 30 days | Number of death at 30-days from the index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Stroke | 30-days | Total Number of Participants with a Stroke. |
Countries
Austria, France, Germany, United Kingdom
Participant flow
Recruitment details
One patient withdrew from the study prior to procedure and one patient did not continue to procedure due to poor health.
Pre-assignment details
Two enrolled subjects did not enter the procedure room.
Participants by arm
| Arm | Count |
|---|---|
| TAVR-TA Transcatheter valve replacement with transapical access
SAPIEN XT™ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach | 218 |
| Total | 218 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 124 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Site early discontinuation | 2 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | TAVR-TA |
|---|---|
| Age, Continuous | 81.2 Years STANDARD_DEVIATION 5.46 |
| Logistic EuroSCORE | 24.0 Units on a scale STANDARD_DEVIATION 7.27 |
| NYHA Class Class I/II | 36 Participants |
| NYHA Class Class III/IV | 182 Participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 124 / 218 |
| other Total, other adverse events | 212 / 218 |
| serious Total, serious adverse events | 201 / 218 |
Outcome results
Primary
Number of Deaths
Number of death at 30-days from the index procedure.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAVR-TA | Number of Deaths | 16 Participants |
Secondary
Number of Participants With a Stroke
Total Number of Participants with a Stroke.
Time frame: 30-days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAVR-TA | Number of Participants With a Stroke | 4 Participants |