Aortic Stenosis
Conditions
Keywords
S3iCAP, SAPIEN 3, Transfemoral, Commander, Certitude, TAVR, TAVI, Aortic stenosis, THV, Transcatheter Heart Valve, TVT, TVTR
Brief summary
Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.
Detailed description
This multi-center, single arm registry will provide continued access of the Edwards SAPIEN 3 Transcatheter Heart Valve and delivery systems to severe aortic stenosis patients at intermediate risk for standard aortic valve replacement. Patient data will be entered into the TVT Registry (TVTR) from screening through 1 year including the collection of 5 year follow-up through CMS.
Interventions
DEVICESAPIEN S3 valve
Transcatheter aortic valve replacement
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
1. Patients must be covered by Medicare. This will enable Edwards to link to the CMS database for long term follow-up through 5 years. No other insurance provider will be accepted. 2. Assessment of intermediate surgical risk defined as STS 4-8% or heart team assessment of intermediate risk factors. 3. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \> 40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of \< 0.8 cm2 or indexed EOA \< 0.5 cm2/m2. Qualifying echo must be within 60 days of the date of the procedure. 4. Aortic valve annulus area range (273mm2-680 mm2) per 3D imaging (echo, CT, or MRI). 5. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater. 6. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient. 7. Heart team agrees (a priori) on treatment strategy for concomitant coronary disease (if present). 8. 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 Institutional Review Board (IRB) of the respective clinical site. 9. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.
Exclusion criteria
1. Heart team assessment of inoperability (including examining cardiac surgeon). 2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \[(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\]. 3. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified. 4. Mixed aortic valve disease (aortic stenosis and aortic re-regurgitation with predominant aortic regurgitation \>3+). 5. Pre-existing mechanical or bioprosthetic valve in any position. 6. Complex coronary artery disease: 1. Unprotected left main coronary artery 2. Syntax score \> 32 (in the absence of prior revascularization) 7. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD is not considered
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | 30 days | Number of deaths |
| Stroke | 30 days | Number of participants with stroke |
| Aortic Valve Reintervention | 30 days | Number of participants with aortic valve reintervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned Vascular Surgery or Intervention | 30 days | Number of participants with unplanned vascular surgery or intervention |
| Retroperitoneal Bleeds | 30 days | Number of participants with retroperitoneal bleed |
| Annular Dissection | 30 days | Number of participants with annular dissection |
| Genitourinary Bleed | 30 days | Number of participants with genitourinary bleeding |
| Bleeding at Access Site | 30 days | Number of participants with bleeding at the access site |
| Gastrointestinal Bleed | 30 days | Number of participants with gastrointestinal bleeding |
| Aortic Dissection | 30 days | Number of participants with aortic dissection |
| Major Access Vascular Site Complication | 30 days | Number of participants with major vascular complications |
Countries
Canada, United States
Participant flow
Recruitment details
Recruitment took place from January 2015 to August 2016. Subjects in this trial were entered into the TVT Registry. Of the 1822 subjects enrolled in the trial, 1814 subjects received the study device.
Pre-assignment details
Participants that did not receive an Edwards device were not followed in the trial.
Participants by arm
| Arm | Count |
|---|---|
| SAPIEN 3 Intermediate risk patients receiving the SAPIEN S3 valve with Commander or Certitude delivery system. | 1,814 |
| Total | 1,814 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 87 |
| Overall Study | Did not receive Study Device | 8 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Missed Visit | 87 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | SAPIEN 3 |
|---|---|
| Age, Continuous | 80.7 years STANDARD_DEVIATION 6 |
| New York Heart Association (NYHA) Class Not Assessed | 1 Participants |
| New York Heart Association (NYHA) Class NYHA I | 0 Participants |
| New York Heart Association (NYHA) Class NYHA II | 682 Participants |
| New York Heart Association (NYHA) Class NYHA III | 1041 Participants |
| New York Heart Association (NYHA) Class NYHA IV | 90 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 67 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) White | 1705 Participants |
| Sex: Female, Male Female | 786 Participants |
| Sex: Female, Male Male | 1028 Participants |
| Society of Thoracic Surgeons (STS) Score | 4.4 units on a scale STANDARD_DEVIATION 1.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 87 / 1,814 |
| other Total, other adverse events | 0 / 1,814 |
| serious Total, serious adverse events | 818 / 1,814 |
Outcome results
Primary
Aortic Valve Reintervention
Number of participants with aortic valve reintervention
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Aortic Valve Reintervention | 3 Participants |
Primary
Aortic Valve Reintervention
Number of participants with aortic valve reintervention
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Aortic Valve Reintervention | 11 Participants |
Primary
Death
Number of deaths
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Death | 12 Participants |
Primary
Death
Number of deaths
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Death | 87 Participants |
Primary
Stroke
Number of participants with stroke
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Stroke | 40 Participants |
Primary
Stroke
Number of participants with stroke
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Stroke | 63 Participants |
Secondary
Annular Dissection
Number of participants with annular dissection
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Annular Dissection | 1 Participants |
Secondary
Aortic Dissection
Number of participants with aortic dissection
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Aortic Dissection | 5 Participants |
Secondary
Bleeding at Access Site
Number of participants with bleeding at the access site
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Bleeding at Access Site | 32 Participants |
Secondary
Gastrointestinal Bleed
Number of participants with gastrointestinal bleeding
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Gastrointestinal Bleed | 2 Participants |
Secondary
Genitourinary Bleed
Number of participants with genitourinary bleeding
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Genitourinary Bleed | 12 Participants |
Secondary
Major Access Vascular Site Complication
Number of participants with major vascular complications
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Major Access Vascular Site Complication | 20 Participants |
Secondary
Retroperitoneal Bleeds
Number of participants with retroperitoneal bleed
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Retroperitoneal Bleeds | 6 Participants |
Secondary
Unplanned Vascular Surgery or Intervention
Number of participants with unplanned vascular surgery or intervention
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAPIEN 3 | Unplanned Vascular Surgery or Intervention | 51 Participants |