Aortic Valve Stenosis
Conditions
Keywords
Sapien Valve, Cardiovascular Diseases, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transfemoral, 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), its transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.
Detailed description
Edwards Lifesciences obtained CE marking authorization for transfemoral delivery / implantation of the Edwards SAPIEN™ transcatheter heart valve (model 9000TFX) using the RetroFlex™ delivery system in August 2007 and introduced these devices for commercial distribution in the European Economic Area (EEA) in October 2007. Clinical Sites: Up to 11 sites in Europe
Interventions
DEVICESapien XT™ transcatheter heart valve and delivery system
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
All candidates for this study must meet all of the following inclusion criteria: 1. Patients must have co-morbidities such that the surgeon (Co Investigator) and interventional cardiologist (Principal Investigator) concur that the predicted risk of operative mortality is \> 15% with a minimum STS Risk Calculator score of ≥ 10 and/or Logistic EuroSCORE of \> 20%. 2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater. 3. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided a written informed consent that has been approved by the reviewing Ethics Committee (EC) of the respective clinical site. 4. Subject is willing to comply with specified follow up evaluations, including possible coronary angiography and transesophageal echocardiography. 5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Exclusion criteria
1. Aortic valve is a congenital unicuspid or bicuspid valve, or is non-calcified. 2. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+). 3. Any therapeutic invasive cardiac procedure, other than BAV, performed within 30 days of the index procedure (or 6 months if the procedure was a drug eluting coronary stent implantation).
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 from the index procedure | Total number of participates with a stroke. |
Countries
Belgium, France, Germany, United Kingdom
Participant flow
Recruitment details
One patient withdrew prior to procedure. Prior to procedure, two patients were noted as having significant co-morbidities not accounted for by the Euroscore, therefore they were exited from the trial prior to procedure.
Pre-assignment details
Three enrolled subjects did not enter the procedure room.
Participants by arm
| Arm | Count |
|---|---|
| TAVR Transaortic Valve Replacement
Sapien XT™ transcatheter heart valve and delivery system | 211 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 129 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | TAVR |
|---|---|
| Age, Continuous | 83.2 Years STANDARD_DEVIATION 5.54 |
| Sex: Female, Male Female | 142 Participants |
| Sex: Female, Male Male | 69 Participants |
| STS Risk Score | 9.1 Units on Scale STANDARD_DEVIATION 6.29 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 129 / 211 |
| other Total, other adverse events | 192 / 211 |
| serious Total, serious adverse events | 193 / 211 |
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 | Number of Deaths | 21 Participants |
Secondary
Number of Participants With a Stroke
Total number of participates with a stroke.
Time frame: 30 days from the index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAVR | Number of Participants With a Stroke | 9 Participants |