Symptomatic Aortic Stenosis
Conditions
Keywords
aortic stenosis, aortic valve stenosis, valvular heart disease, aortic valve replacement, transcatheter aortic valve implantation, TAVI
Brief summary
The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
Detailed description
Data will be collected at baseline, procedure, discharge, 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.
Interventions
DEVICETranscatheter Aortic Valve Implantation
Placement of the SJM Portico aortic valve with a transfemoral delivery system
Sponsors
Abbott Medical Devices
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
1. Subject has given written study Informed Consent for participation prior to procedure. 2. Subject is ≥ 18 years of age or legal age in host country. 3. Subject's aortic annulus diameter meets the range indicated in the Instructions for use as measured by echocardiogram (echo) or CT conducted within the past 90 days. 4. Subject has senile degenerative aortic stenosis with echocardiography (echo) derived mean gradient \>40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of \<1.0 cm2 (or aortic valve area index ≤ 0.6 cm2/m2). (Baseline measurement taken by echo within 30 days of procedure). 5. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater. 6. Subject is deemed high operable risk and suitable for TAVI per the medical opinion of the Subject Selection Committee (See Section 3.1 for the definition of the Subject Selection Committee) 7. Subject's predicted operative mortality or serious, irreversible morbidity risk is \<50% at 30 days. 8. In the opinion of the Subject Selection Committee and based upon angiographic measurements, the subject has suitable peripheral vessels and aorta to allow for access of the 18 French delivery system. 9. Subject has structurally normal cardiac anatomy. 10. Subject is willing and able to comply with all required follow-up evaluations.
Exclusion criteria
1. Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of the index procedure. 2. Subject has carotid artery disease requiring intervention. 3. Subject has evidence of a myocardial infarction (MI) within the past 6 months (≤180 days) of the index procedure. 4. Subject has hypertrophic cardiomyopathy. 5. Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography. 6. Subject has mitral or tricuspid valvular regurgitation (\>grade III) or moderate to severe mitral stenosis. 7. Subject has aortic root angulation \>70 degrees (horizontal aorta). 8. Subject has a pre-existing prosthetic valve or prosthetic ring in any position. 9. Subject refuses blood transfusion or surgical valve replacement. 10. Subject has left ventricular ejection fraction (LVEF) \< 20%. 11. The subject has documented, untreated coronary artery disease (CAD) requiring revascularization. 12. Subject has severe basal septal hypertrophy. 13. Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days of the index procedure. 14. Subject has a history of or has active endocarditis. 15. Subject has echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 16. Subject has hemodynamic instability (requiring inotropic support or mechanical heart assistance). 17. Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure. 18. Subject with significant pulmonary disease. 19. Subject has significant chronic steroid use. 20. Subject has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication. 21. Subject has renal insufficiency as evidenced by a serum creatinine \> 3.0 mg/dL (265µmol/L) or end-stage renal disease requiring chronic dialysis. 22. Subject has morbid obesity defined as BMI ≥ 40. 23. Subject's iliac arteries have severe calcification, tortuosity (\>two 90 degree bends), diameter \<6mm, or subject has had an aorto-femoral bypass. 24. Subject has ongoing infection or sepsis. 25. Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy). 26. Subject has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation. 27. Subject has significant aortic disease, including: * aortic abdominal aneurysm (AAA) ≥ 4cm * thoracic aneurysm (defined as a maximal luminal diameter of 5 cm or greater) * marked tortuosity * significant aortic arch atheroma or narrowing of the abdominal or thoracic aorta * severe tortuosity of the thoracic aorta. 28. Subject has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries. 29. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to the index procedure. 30. Subject is currently participating in another investigational drug or device study. 31. Subject requires emergency surgery for any reason. 32. Subject has a life expectancy \< 12 months. 33. Subject has other medical, social or psychological conditions that, in the opinion of the Subject Selection Committee, preclude the subject from study participation. 34. Subject is suffering from dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits. 35. Subject has a known allergy to contrast media, nitinol alloys, porcine tissue, or bovine tissue.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Mortality | 30 days | Number of participants that reported all cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Select Cardiovascular Adverse Events | 30 days | Number of participants with select cardiovascular adverse events |
| Participant NYHA Classification at Day 30 | day 30 | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256. |
| Number of Participants With Acute Device Success | 7 days | 1. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system 2. Correct position of the device in the proper anatomical location 3. Intended performance of the prosthetic heart valve (Aortic Valve Area \>1.2 cm2 and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, without moderate or severe prosthetic valve AR) 4. Only one valve implanted in the proper anatomical location |
Countries
Australia, Denmark, Germany, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transfemoral Transfemoral access | 222 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 29 |
| Overall Study | Withdrawal by Subject | 32 |
Baseline characteristics
| Characteristic | Transfemoral |
|---|---|
| Age, Continuous | 83.0 years STANDARD_DEVIATION 4.6 |
| History of atrial fibrillation | 85 Participants |
| History of pulmonary hypertension | 68 Participants |
| NYHA class III/IV | 175 Participants |
| Porcelain aorta | 8 Participants |
| Region of Enrollment Australia | 15 Participants |
| Region of Enrollment Denmark | 3 Participants |
| Region of Enrollment Germany | 141 Participants |
| Region of Enrollment Netherlands | 15 Participants |
| Region of Enrollment United Kingdom | 48 Participants |
| Renal failure/insufficiency | 73 Participants |
| Sex: Female, Male Female | 165 Participants |
| Sex: Female, Male Male | 57 Participants |
| STS risk score of mortality | 5.8 Percentage STANDARD_DEVIATION 3.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 29 / 222 |
| other Total, other adverse events | 18 / 222 |
| serious Total, serious adverse events | 102 / 222 |
Outcome results
Primary
All Cause Mortality
Number of participants that reported all cause mortality
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transfemoral | All Cause Mortality | 8 Participants |
Secondary
Number of Participants With Acute Device Success
1. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system 2. Correct position of the device in the proper anatomical location 3. Intended performance of the prosthetic heart valve (Aortic Valve Area \>1.2 cm2 and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, without moderate or severe prosthetic valve AR) 4. Only one valve implanted in the proper anatomical location
Time frame: 7 days
Population: Successful vascular access, delivery and deployment of the device
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transfemoral | Number of Participants With Acute Device Success | 216 Participants |
Secondary
Number of Select Cardiovascular Adverse Events
Number of participants with select cardiovascular adverse events
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Transfemoral | Number of Select Cardiovascular Adverse Events | Cardiovascular death | 8 participants |
| Transfemoral | Number of Select Cardiovascular Adverse Events | Myocardial Infarction | 7 participants |
| Transfemoral | Number of Select Cardiovascular Adverse Events | Stage 3 Acute kidney injury | 3 participants |
| Transfemoral | Number of Select Cardiovascular Adverse Events | Disabling (major) stroke | 7 participants |
| Transfemoral | Number of Select Cardiovascular Adverse Events | Non-disabling (minor) stroke | 5 participants |
| Transfemoral | Number of Select Cardiovascular Adverse Events | Life threatening or disabling bleeding | 8 participants |
Secondary
Participant NYHA Classification at Day 30
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.
Time frame: day 30
Population: Analysis for participants that completed visit and assessment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Transfemoral | Participant NYHA Classification at Day 30 | NYHA 1 | 52 Participants |
| Transfemoral | Participant NYHA Classification at Day 30 | NYHA II | 105 Participants |
| Transfemoral | Participant NYHA Classification at Day 30 | NYHA III | 22 Participants |
| Transfemoral | Participant NYHA Classification at Day 30 | NYHA IV | 2 Participants |