Aortic Valve Stenosis
Conditions
Keywords
TAVI, Valvular heart disease, Transcatheter aortic valve implantation
Brief summary
Expand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System
Detailed description
Expand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System to place a Portico transcatheter aortic valve through an alternative access site, specifically subclavian/axillary or transaortic (TAo) in subjects with symptomatic severe native aortic stenosis who are considered high surgical risk
Interventions
DEVICETransaortic TAVR Implant
Transaortic TAVR implant
DEVICESubclavian /Axillary TAVR implant
Subclavian /Axillary TAVR implant
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Portico TF and ALT Delivery System
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject has provided written informed consent prior to uploading CT scan to core lab. 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 multislice CT conducted within 180 days prior to the index procedure. 4. Subject has senile degenerative aortic stenosis seen by echocardiography within 90 days of index procedure as measured by: 1. mean gradient \>40 mmHg 2. Peak velocity ≥ 4.0 m/s 3. Doppler Velocity Index \<0.25 4. Aortic valve area (AVA) of ≤ 1.0 cm2 or indexed EOA ≤ 0.6 cm2/m2). 5. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of Class II, or greater or other symptoms of aortic stenosis (e.g. syncope). 6. Subject is deemed high operable risk and preferred TAVI delivery route is alternate access (subclavian/axillary or direct aortic) per the medical opinion of the center's heart team and confirmed by SSC. * High risk is defined as an STS mortality \> 8% or documented heart team agreement ≥ high risk for SAVR due to frailty or co-morbidities
Exclusion criteria
1. Subject is unwilling or unable to comply with all study-required follow-up evaluations. 2. Subject has a documented history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months (less than or equal to 180 days) prior to the index procedure. 3. Subject has carotid artery disease requiring intervention. 4. Subject has evidence of a myocardial infarction (MI) within 30 days prior to patient index procedure. 5. Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography. 6. Subject has severe mitral valvular regurgitation. 7. Subject has severe mitral stenosis. 8. Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position. 9. Subject refuses any blood product transfusion. 10. Subject has resting left ventricular ejection fraction (LVEF) less than 20%. 11. Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization. 12. Subject has had a percutaneous interventional or other invasive cardiovascular or peripheral vascular procedure less than or equal to 14 days prior to index procedure. 13. Subject has severe basal septal hypertrophy that would interfere with transcatheter aortic valve placement. 14. Subject has a history of, or is currently diagnosed with, endocarditis. 15. There is imaging evidence of intracardiac mass, thrombus, or vegetation. 16. Subject is considered hemodynamically unstable (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 severe pulmonary disease as determined by STS score. 19. Subject is on chronic oral steroid therapy. 20. Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication. 21. Subject has renal insufficiency as evidenced by a serum creatinine greater than 3.0 mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic dialysis. 22. Subject has morbid obesity defined as a BMI greater than or equal to 40. 23. Subject has ongoing infection or sepsis. 24. Subject has uncontrolled blood dyscrasias as defined: leukopenia (WBC\<3000 mm3), acute anemia (Hb\<9 mg/dL), thrombocytopenia (platelet count \<50,000 cells/mm3,). 25. Anatomy falling outside the recommended values in the IFU, unless specifically approved by the Subject Selection Committee. 26. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure. 27. Subject is currently participating in another investigational drug or device study, unless approved by the Sponsor. 28. Subject has/had emergency surgery for any reason within 30 days of the index procedure. 29. Subject has a life expectancy less than 1 year. 30. Subject has other medical, social or psychological conditions that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude the subject from study participation. 31. Subject is diagnosed with a state of dementia which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits. 32. Subject has a documented allergy to contrast media that cannot adequately be treated, nitinol alloys, porcine tissue, or bovine tissue. 33. Significant aortic disease including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater 34. Subjects with severe pulmonary hypertension and severe RV dysfunction 35. Subjects with hypertrophic cardiomyopathy Transaortic Subject Cohort Specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Vascular Complications | 30 Days | Major Vascular complication is defined as * Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudo-aneurysm or * Access site or access-related vascular injury leading to death, life-threatening or major bleeding, visceral ischaemia or neurological impairment or * Distal embolization from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage or * The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment or * Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram or * Surgery for access site-related nerve injury or * Permanent access site-related nerve injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Mortality | 30 Days | Any 1 of the following criteria: * Death due to proximate cardiac cause (e.g., myocardial infarction, cardiac tamponade, worsening heart failure) * Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease. * All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure * All valve-related deaths including structural or nonstructural valve dysfunction or other valve-related adverse events * Sudden or unwitnessed death * Death of unknown cause |
| Number of Participants With Disabling Stroke | 30 Days | Disabling stroke is an mRS score of 2 or more at 90 days and an increase of at least 1 mRS category from an individual's prestroke baseline |
| Number of Participants With Non-disabling Strokes | 30 Days | Non-disabling is an mRS score of \<2 at 90 days or 1 that does not result in an increase of at least 1 mRS category from an individual's prestroke baseline |
| Number of Participants With Life Threatening Bleeding Requiring Transfusion | 30 Days | Life threatening bleeding requiring transfusion * Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0 g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND * Does not meet criteria of life-threatening or disabling bleeding |
| Number of Participants With Acute Kidney Injury Requiring Dialysis | 30 Days | Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output \<0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria |
| Number of All- Cause Mortality | 30 Days | — |
| Number of Participants With Moderate and Severe Aortic Regurgitation | 1 year | — |
| Change in NYHA Class From Baseline to 30 Days | Baseline to 30 days | New York Heart Association (NYHA) functional classification provides a way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain. 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. |
| Change in Six Minute Walk Test From Baseline as Compared to 30 Days | Baseline to 30 days | The Six Minute Walk Test (6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status. |
| Change in Effective Orifice Area From Baseline as Compared to 30 Days | Baseline to 30 days. | Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve. |
| Number of Participants With Overall Acute Device Success | 7 days | Acute device success is defined as a subject who achieves a) successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system, b) correct position of the device in the proper anatomical location, c) intended performance of the prosthetic heart valve, and d) only 1 valve implanted in the proper anatomical location. Device success is a 'technical' composite endpoint meant to characterize the acute device and procedural factors which underlie vascular access, delivery, and performance of the TAVI system. Echocardiography should be routinely utilized as the standard for measuring prosthetic valve stenosis and regurgitation immediately after TAVI, and should always be performed in a resting state, either within 24-48 h after the index procedure or before hospital discharge. |
| Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA | 30 Days | Stroke is an acute symptomatic episode of neurological dysfunction attributed to a vascular cause. Transient Ischemic Attack (TIA) is a transient (less than 24 hrs) episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. No evidence of infarction if imaging performed. Encephalopathy is defined as altered mental state (e.g., seizures, delirium, confusion, hallucinations, dementia, coma, psychiatric episode). |
Countries
Denmark, Germany, Italy, Netherlands, Switzerland
Participant flow
Recruitment details
A total of 64 subjects were enrolled and undergone implant with a Portico Transcatheter Aortic Valve via an alternative access route at 10 sites between March 29, 2017 and June 04, 2018.
Pre-assignment details
Of the 64 subjects, 45 subjects were implanted via subclavian/axillary access and 19 via transaortic access. Enrollment in the transaortic arm was stopped after 15 months due to a slow enrollment rate. All subjects will be followed through 1-year post implant.
Participants by arm
| Arm | Count |
|---|---|
| Subclavian/Axillary Access Arm Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site. | 45 |
| Transaortic Arm Subjects who underwent Transaortic TAVR implant. | 19 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 4 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Subclavian/Axillary Access Arm | Transaortic Arm | Total |
|---|---|---|---|
| Age, Continuous | 81.7 years STANDARD_DEVIATION 5.9 | 77.1 years STANDARD_DEVIATION 7.2 | 80.3 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 45 Participants | 19 Participants | 64 Participants |
| Region of Enrollment Denmark | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Germany | 5 Participants | 3 Participants | 8 Participants |
| Region of Enrollment Italy | 14 Participants | 3 Participants | 17 Participants |
| Region of Enrollment Netherlands | 23 Participants | 13 Participants | 36 Participants |
| Region of Enrollment Switzerland | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 26 Participants | 10 Participants | 36 Participants |
| Sex: Female, Male Male | 19 Participants | 9 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 45 | 4 / 19 |
| other Total, other adverse events | 30 / 45 | 9 / 19 |
| serious Total, serious adverse events | 21 / 45 | 15 / 19 |
Outcome results
Primary
Number of Participants With Major Vascular Complications
Major Vascular complication is defined as * Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudo-aneurysm or * Access site or access-related vascular injury leading to death, life-threatening or major bleeding, visceral ischaemia or neurological impairment or * Distal embolization from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage or * The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment or * Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram or * Surgery for access site-related nerve injury or * Permanent access site-related nerve injury
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of Participants With Major Vascular Complications | 2 Participants |
| Transaortic Access Arm | Number of Participants With Major Vascular Complications | 1 Participants |
Secondary
Cardiovascular Mortality
Any 1 of the following criteria: * Death due to proximate cardiac cause (e.g., myocardial infarction, cardiac tamponade, worsening heart failure) * Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease. * All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure * All valve-related deaths including structural or nonstructural valve dysfunction or other valve-related adverse events * Sudden or unwitnessed death * Death of unknown cause
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Cardiovascular Mortality | 0 Participants |
| Transaortic Access Arm | Cardiovascular Mortality | 2 Participants |
Secondary
Cardiovascular Mortality
Any 1 of the following criteria: * Death due to proximate cardiac cause (e.g., myocardial infarction, cardiac tamponade, worsening heart failure) * Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease. * All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure * All valve-related deaths including structural or nonstructural valve dysfunction or other valve-related adverse events * Sudden or unwitnessed death * Death of unknown cause
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Cardiovascular Mortality | 1 Participants |
| Transaortic Access Arm | Cardiovascular Mortality | 4 Participants |
Secondary
Change in Effective Orifice Area From Baseline as Compared to 30 Days
Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.
Time frame: Baseline to 30 days.
Population: We had presented the data only for the participants who had an outcome at baseline and at 30 days (paired data).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subclavian/Axillary Access Arm | Change in Effective Orifice Area From Baseline as Compared to 30 Days | 1.1 cm2 | Standard Deviation 0.3 |
| Transaortic Access Arm | Change in Effective Orifice Area From Baseline as Compared to 30 Days | 1.0 cm2 | Standard Deviation 0.3 |
Secondary
Change in NYHA Class From Baseline to 30 Days
New York Heart Association (NYHA) functional classification provides a way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain. 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.
Time frame: Baseline to 30 days
Population: We had presented the data only for the participants who had an outcome at baseline and at 30 days (paired data).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subclavian/Axillary Access Arm | Change in NYHA Class From Baseline to 30 Days | Improvement from BL NYHA II to 30days NYHA I | 3 Participants |
| Subclavian/Axillary Access Arm | Change in NYHA Class From Baseline to 30 Days | Improvement from BL NYHA III to 30days NYHA I & II | 25 Participants |
| Subclavian/Axillary Access Arm | Change in NYHA Class From Baseline to 30 Days | Improvement fromBL NYHA IV to 30days NYHA I,II,III | 3 Participants |
| Subclavian/Axillary Access Arm | Change in NYHA Class From Baseline to 30 Days | Improvement from Baseline (BL) NYHA I to 30days | 0 Participants |
| Transaortic Access Arm | Change in NYHA Class From Baseline to 30 Days | Improvement fromBL NYHA IV to 30days NYHA I,II,III | 0 Participants |
| Transaortic Access Arm | Change in NYHA Class From Baseline to 30 Days | Improvement from Baseline (BL) NYHA I to 30days | 0 Participants |
| Transaortic Access Arm | Change in NYHA Class From Baseline to 30 Days | Improvement from BL NYHA II to 30days NYHA I | 2 Participants |
| Transaortic Access Arm | Change in NYHA Class From Baseline to 30 Days | Improvement from BL NYHA III to 30days NYHA I & II | 8 Participants |
Secondary
Change in Six Minute Walk Test From Baseline as Compared to 30 Days
The Six Minute Walk Test (6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.
Time frame: Baseline to 30 days
Population: We had presented the data only for the participants who had an outcome at baseline and at 30 days (paired data).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subclavian/Axillary Access Arm | Change in Six Minute Walk Test From Baseline as Compared to 30 Days | 46.3 Meter | Standard Deviation 94.7 |
| Transaortic Access Arm | Change in Six Minute Walk Test From Baseline as Compared to 30 Days | 6.0 Meter | Standard Deviation 87.3 |
Secondary
Number of All- Cause Mortality
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of All- Cause Mortality | 2 Participants |
| Transaortic Access Arm | Number of All- Cause Mortality | 4 Participants |
Secondary
Number of All- Cause Mortality
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of All- Cause Mortality | 1 Participants |
| Transaortic Access Arm | Number of All- Cause Mortality | 2 Participants |
Secondary
Number of Participants With Acute Kidney Injury Requiring Dialysis
Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output \<0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of Participants With Acute Kidney Injury Requiring Dialysis | 0 Participants |
| Transaortic Access Arm | Number of Participants With Acute Kidney Injury Requiring Dialysis | 0 Participants |
Secondary
Number of Participants With Acute Kidney Injury Requiring Dialysis
Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output \<0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of Participants With Acute Kidney Injury Requiring Dialysis | 0 Participants |
| Transaortic Access Arm | Number of Participants With Acute Kidney Injury Requiring Dialysis | 0 Participants |
Secondary
Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA
Stroke is an acute symptomatic episode of neurological dysfunction attributed to a vascular cause. Transient Ischemic Attack (TIA) is a transient (less than 24 hrs) episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. No evidence of infarction if imaging performed. Encephalopathy is defined as altered mental state (e.g., seizures, delirium, confusion, hallucinations, dementia, coma, psychiatric episode).
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA | 5 Participants |
| Transaortic Access Arm | Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA | 0 Participants |
Secondary
Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA
Stroke is an acute symptomatic episode of neurological dysfunction attributed to a vascular cause. Transient Ischemic Attack (TIA) is a transient (less than 24 hrs) episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. No evidence of infarction if imaging performed. Encephalopathy is defined as altered mental state (e.g., seizures, delirium, confusion, hallucinations, dementia, coma, psychiatric episode).
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA | 5 Participants |
| Transaortic Access Arm | Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA | 0 Participants |
Secondary
Number of Participants With Disabling Stroke
Disabling stroke is an mRS score of 2 or more at 90 days and an increase of at least 1 mRS category from an individual's prestroke baseline
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of Participants With Disabling Stroke | 1 Participants |
| Transaortic Access Arm | Number of Participants With Disabling Stroke | 0 Participants |
Secondary
Number of Participants With Disabling Stroke
Disabling stroke is an mRS score of 2 or more at 90 days and an increase of at least 1 mRS category from an individual's prestroke baseline
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of Participants With Disabling Stroke | 1 Participants |
| Transaortic Access Arm | Number of Participants With Disabling Stroke | 0 Participants |
Secondary
Number of Participants With Life Threatening Bleeding Requiring Transfusion
Life threatening bleeding requiring transfusion * Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0 g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND * Does not meet criteria of life-threatening or disabling bleeding
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of Participants With Life Threatening Bleeding Requiring Transfusion | 2 Participants |
| Transaortic Access Arm | Number of Participants With Life Threatening Bleeding Requiring Transfusion | 2 Participants |
Secondary
Number of Participants With Life Threatening Bleeding Requiring Transfusion
Life threatening bleeding requiring transfusion * Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0 g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND * Does not meet criteria of life-threatening or disabling bleeding
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of Participants With Life Threatening Bleeding Requiring Transfusion | 2 Participants |
| Transaortic Access Arm | Number of Participants With Life Threatening Bleeding Requiring Transfusion | 2 Participants |
Secondary
Number of Participants With Moderate and Severe Aortic Regurgitation
Time frame: 1 year
Population: The number of participants who were available at that time point were included
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of Participants With Moderate and Severe Aortic Regurgitation | 1 Participants |
| Transaortic Access Arm | Number of Participants With Moderate and Severe Aortic Regurgitation | 1 Participants |
Secondary
Number of Participants With Non-disabling Strokes
Non-disabling is an mRS score of \<2 at 90 days or 1 that does not result in an increase of at least 1 mRS category from an individual's prestroke baseline
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of Participants With Non-disabling Strokes | 4 Participants |
| Transaortic Access Arm | Number of Participants With Non-disabling Strokes | 0 Participants |
Secondary
Number of Participants With Non-disabling Strokes
Non-disabling is an mRS score of \<2 at 90 days or 1 that does not result in an increase of at least 1 mRS category from an individual's prestroke baseline
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of Participants With Non-disabling Strokes | 4 Participants |
| Transaortic Access Arm | Number of Participants With Non-disabling Strokes | 0 Participants |
Secondary
Number of Participants With Overall Acute Device Success
Acute device success is defined as a subject who achieves a) successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system, b) correct position of the device in the proper anatomical location, c) intended performance of the prosthetic heart valve, and d) only 1 valve implanted in the proper anatomical location. Device success is a 'technical' composite endpoint meant to characterize the acute device and procedural factors which underlie vascular access, delivery, and performance of the TAVI system. Echocardiography should be routinely utilized as the standard for measuring prosthetic valve stenosis and regurgitation immediately after TAVI, and should always be performed in a resting state, either within 24-48 h after the index procedure or before hospital discharge.
Time frame: 7 days
Population: The number of participants who were available at that time point were included
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subclavian/Axillary Access Arm | Number of Participants With Overall Acute Device Success | 43 Participants |
| Transaortic Access Arm | Number of Participants With Overall Acute Device Success | 14 Participants |