Aortic Regurgitation, Aortic Stenosis, Symptomatic Aortic Stenosis
Conditions
Keywords
TAVI, TAVR, CHINA, SAPIEN XT, High Risk, Transcatheter aortic valve implantation, Transcatheter aortic valve replacement
Brief summary
To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.
Detailed description
Edwards SAPIEN XT™ Transcatheter Heart Valve and NovaFlex+ delivery system will be used for this study.
Interventions
DEVICESAPIEN XT THV with the NovaFlex+ delivery system
Edwards SAPIEN XT™ Transcatheter Heart Valve along with NovaFlex+ delivery system
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects who are considered to be operable and high risk for surgical valve replacement: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE ≤ 40. If STS score is below 8 and/or Logistic EuroSCORE is below 15, patients should have other clinical or anatomical risk factors that would be considered high risk for surgery and documented by the heart team. 2. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: AVA \< 0.8 cm2, Indexed AVA \<0.5 cm2/m2, mean gradient \> 40mmHg, or peak aortic jet velocity \> 4.0m/sec. 3. NYHA Functional Class II or greater. 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 EC of the respective clinical site. 5. The study patient agrees to comply with all required post procedure follow-up visits.
Exclusion criteria
1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment. 2. Aortic valve is a congenital unicuspid or is non-calcified. 3. Aortic valve is bicuspid and the patient is less than 60 years old, or the aortic valve is bicuspid with no raphe (Sievers classification type 0). 4. Anomalous coronary artery that would interfere with proper placement of the valve. 5. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality | 30 days | All of the deaths that occurred in this population regardless of the cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Mortality | 30 days | All of the deaths that occurred in this population due to a cardiovascular issue. |
| Number of Participates With a Stroke | 30 days | Total number of participates with a stroke. |
Countries
China
Participant flow
Recruitment details
Each study site was allowed up to two roll-in patients. Per the protocol, roll-in patients completed all study visits and procedures but were not part of the analysis. Six of the 67 patients enrolled were roll-in patients.
Participants by arm
| Arm | Count |
|---|---|
| Patients With SAPIEN XT THV Patients were implanted with the Edwards SAPIEN XT™ Transcatheter Heart Valve using the NovaFlex+ delivery system. | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Patients With SAPIEN XT THV |
|---|---|
| Age, Continuous | 77.9 years STANDARD_DEVIATION 5.44 |
| NYHA Class Grouped Class I/II | 5 Participants |
| NYHA Class Grouped Class III/IV | 56 Participants |
| Race/Ethnicity, Customized Chinese | 61 Participants |
| Region of Enrollment China | 61 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 35 Participants |
| STS Score | 6.8 units on a scale STANDARD_DEVIATION 3.72 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 61 |
| other Total, other adverse events | 53 / 61 |
| serious Total, serious adverse events | 16 / 61 |
Outcome results
Primary
All-cause Mortality
All of the deaths that occurred in this population regardless of the cause.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With SAPIEN XT THV | All-cause Mortality | 4 Participants |
Secondary
Cardiovascular Mortality
All of the deaths that occurred in this population due to a cardiovascular issue.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With SAPIEN XT THV | Cardiovascular Mortality | 4 Participants |
Secondary
Number of Participates With a Stroke
Total number of participates with a stroke.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With SAPIEN XT THV | Number of Participates With a Stroke | 0 Participants |