Aortic Valve Stenosis
Conditions
Keywords
SAPIEN XT Valve, Cardiovascular Disease, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transapical, Transcatheter, Transfemoral
Brief summary
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical 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 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. 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.
Interventions
DEVICETranscatheter aortic valve implantation
Transcatheter aortic valve implantation via transapical and transfemoral approach
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
* 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 \< 18 mm or \> 25 mm * LVEF \< 20 %
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of the AVA and NYHA Functional Classification | 6 Months | Improvement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 6 months 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 6 months \> 1.0 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 6 months | Death Adverse Event Rate |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAVI - TF Approach Transcatheter aortic valve implantation and transfemoral approach
Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach | 37 |
| TAVI-TA Approach Transcatheter aortic valve implantation - Transapical approach
Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach | 27 |
| Total | 64 |
Baseline characteristics
| Characteristic | TAVI-TA Approach | TAVI - TF Approach | Total |
|---|---|---|---|
| Age, Continuous | 85.9 Years STANDARD_DEVIATION 5.3 | 83.2 Years STANDARD_DEVIATION 6.5 | 84.3 Years STANDARD_DEVIATION 6.1 |
| Arrhythmia | 37.0 % of patricipants | 56.8 % of patricipants | 48.4 % of patricipants |
| Height | 147.47 cm STANDARD_DEVIATION 8.55 | 151.10 cm STANDARD_DEVIATION 7.82 | 149.57 cm STANDARD_DEVIATION 8.27 |
| NYHA II | 51.9 % of Patients | 59.5 % of Patients | 56.3 % of Patients |
| NYHA III/IV | 48.1 % of participants | 40.5 % of participants | 43.8 % of participants |
| Porcelain Aorta | 22.2 % of Participants | 13.5 % of Participants | 17.2 % of Participants |
| Renal Disease | 44.4 % of Participants | 24.3 % of Participants | 32.8 % of Participants |
| Sex: Female, Male Female | 18 Participants | 24 Participants | 42 Participants |
| Sex: Female, Male Male | 9 Participants | 13 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 37 | 5 / 27 |
| other Total, other adverse events | 19 / 37 | 13 / 27 |
| serious Total, serious adverse events | 25 / 37 | 27 / 27 |
Outcome results
Primary
Improvement of the AVA and NYHA Functional Classification
Improvement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 6 months 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 6 months \> 1.0 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA.
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAVI - TF Approach | Improvement of the AVA and NYHA Functional Classification | 38.2 % of participants |
| TAVI-TA Approach | Improvement of the AVA and NYHA Functional Classification | 45.8 % of participants |
Secondary
Death
Death Adverse Event Rate
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAVI - TF Approach | Death | 5.4 percentage of participants |
| TAVI-TA Approach | Death | 18.5 percentage of participants |