Aortic Valve Stenosis
Conditions
Keywords
SAPIEN XT Valve (20mm), Cardiovascular Disease, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transcatheter, Transfemoral, Efficacy endpoints, Indexed Aortic Valve Area, NYHA
Brief summary
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, and crimper accessories. The trial includes a premarket pivotal cohort to evaluate the system performance as well as a post market clinical follow-up phase involving long term follow-up of all patients to evaluate the safety of investigational devices up to 5 years.
Detailed description
Purpose: To evaluate the safety and efficacy of THV-9300 (20mm) for patients who have severe symptomatic aortic stenosis attributed to calcification and degeneration of a valve leaflet and for whom undergoing a surgery safely would be difficult. Enrollment: 15 patients (No.of patients needed: 12) Follow-up: 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 months and annually for 5 years. Clinical sites: 1)Osaka University Hospital, 2)Kurashiki Central Hospital, 3)Sakakibara Heart Institute, 4) Kokura Memorial Hospital
Interventions
DEVICESAPIEN XT NovaFlex delivery system
Transcatheter aortic valve implantation via transfemoral approach.
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
* Patients who were judged difficult to safely undergo AVR * Severe senile degenerative aortic valve stenosis * NYHA Functional Class II or greater * Signed Informed Consent
Exclusion criteria
* Aortic valve is congenital unicuspid or bicuspid * Annulus size between \< 16 mm or \> 19 mm * LVEF \< 20 %
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NYHA Improvement and AVA >= 0.65 cm2 | 1 year | Improvement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 1 year after the procedure. NYHA functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I-IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort. The AVA at 1 year \>= 0.65 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA. Note: One patient did not complete a 6-month echo. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 20-mm TF-TAVR Patients with symptomatic severe aortic stenosis received a 20 mm SAPIEN XT valve through the transfemoral procedure. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
Baseline characteristics
| Characteristic | 20-mm TF-TAVR |
|---|---|
| Age, Continuous | 82.2 Years STANDARD_DEVIATION 8.1 |
| Arrhythmia | 4 Participants |
| Diabetes | 6 Participants |
| NYHA Class III/IV | 11 Participants |
| Porcelain Aorta | 3 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 17 |
| other Total, other adverse events | 11 / 17 |
| serious Total, serious adverse events | 8 / 17 |
Outcome results
Primary
NYHA Improvement and AVA >= 0.65 cm2
Improvement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 1 year after the procedure. NYHA functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I-IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort. The AVA at 1 year \>= 0.65 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA. Note: One patient did not complete a 6-month echo.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAVI-TF Approach | NYHA Improvement and AVA >= 0.65 cm2 | 14 Participants |