Aortic Stenosis
Conditions
Brief summary
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be unable to undergo safe open surgical therapy and have the benefits of the study valve implantation. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Detailed description
1-year mortality after the study valve implantation will be compared to the performance goal based on the literature review of clinical outcomes for dialysis patients who underwent surgical aortic valve replacement. Data will be collected from all patients for up to five years following the index valve replacement procedure.
Interventions
Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic 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
* Patient is determined by the heart team to be unable to undergo open surgical therapy and have the benefits of the study valve implantation. * Patient has senile degenerative aortic valve stenosis * Patient has been on dialysis (hemodialysis or peritoneal dialysis) in stable condition for ≥ 3 months. * Patient has appropriate aortic valve annulus size measured by TEE or 3D-CT.
Exclusion criteria
* Patient has evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure. * Patient has a congenital unicuspid or bicuspid aortic valve, or non-calcified aortic valve. * Patient has severe aortic valve regurgitation. * Patient has severe mitral valve regurgitation. * Patient has an experience of any therapeutic invasive cardiac procedures within 30 days prior to the index procedure. Implantation of a permanent pacemaker or balloon valvuloplasty for bridging to procedure after a qualifying echo are not considered exclusionary. * Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 1 year | Number of Deaths |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | 30 days | Number of patients with device success, defined as absence of procedural mortality, correct positioning of a study valve into the proper anatomical location, and intended performance of the study valve (no prosthesis-patient mismatch and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/s, and no moderate or severe prosthetic valve regurgitation). |
| Hospitalization Length of Stay | 7 days | Discharge is defined as an average for 7 days |
Countries
Japan
Participant flow
Recruitment details
Thirty-eight subjects were consented to the trial. Two subjects withdrawn from the study prior to the TAVI procedure. One subject had a gastrointestinal bleed prior to the procedure and the other subject had surgery per the decision of the surgeon.
Pre-assignment details
Eight of the 36 subjects were treated as bailout due to the non-nominal volumes. The primary analysis was performed on the patients with nominal volume (n=28).
Participants by arm
| Arm | Count |
|---|---|
| SAPIEN 3 Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System
Transcatheter Aortic Valve Implantation (TAVI): Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
Baseline characteristics
| Characteristic | SAPIEN 3 |
|---|---|
| Age, Continuous | 79.2 years STANDARD_DEVIATION 5.2 |
| Duration of Dialysis | 11.52 Years STANDARD_DEVIATION 10.47 |
| Race/Ethnicity, Customized Japanese | 28 Participants |
| Region of Enrollment Japan | 28 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 19 Participants |
| STS Score | 14.34 Units on a Scale STANDARD_DEVIATION 6.23 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 28 |
| other Total, other adverse events | 19 / 28 |
| serious Total, serious adverse events | 17 / 28 |
Outcome results
Primary
Mortality
Number of Deaths
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Mortality | 3 Participants |
Secondary
Device Success
Number of patients with device success, defined as absence of procedural mortality, correct positioning of a study valve into the proper anatomical location, and intended performance of the study valve (no prosthesis-patient mismatch and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/s, and no moderate or severe prosthetic valve regurgitation).
Time frame: 30 days
Population: Echo data was missing for one patient.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Device Success | 20 Participants |
Secondary
Hospitalization Length of Stay
Discharge is defined as an average for 7 days
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAPIEN 3 | Hospitalization Length of Stay | 6.3 Days | Standard Deviation 2.2 |