Trial Outcomes & Findings for Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access (NCT NCT03056573)
NCT ID: NCT03056573
Last Updated: 2025-02-11
Results Overview
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
COMPLETED
NA
64 participants
30 Days
2025-02-11
Participant Flow
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.
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.
Participant milestones
| Measure |
Subclavian/Axillary Access Arm
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
19
|
|
Overall Study
COMPLETED
|
40
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Subclavian/Axillary Access Arm
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Overall Study
Death
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access
Baseline characteristics by cohort
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
81.7 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
77.1 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
80.3 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
45 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 DaysMajor 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
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of Participants With Major Vascular Complications
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 DaysOutcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of All- Cause Mortality
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 YearOutcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of All- Cause Mortality
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 DaysAny 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
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Cardiovascular Mortality
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearAny 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
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Cardiovascular Mortality
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 DaysDisabling 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
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of Participants With Disabling Stroke
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 YearDisabling 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
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of Participants With Disabling Stroke
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 DaysNon-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
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of Participants With Non-disabling Strokes
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 YearNon-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
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of Participants With Non-disabling Strokes
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 DaysLife 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
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of Participants With Life Threatening Bleeding Requiring Transfusion
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 YearLife 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
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of Participants With Life Threatening Bleeding Requiring Transfusion
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 DaysIncrease 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
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of Participants With Acute Kidney Injury Requiring Dialysis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 YearIncrease 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
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of Participants With Acute Kidney Injury Requiring Dialysis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 DaysStroke 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).
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 YearStroke 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).
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The number of participants who were available at that time point were included
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=28 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=13 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of Participants With Moderate and Severe Aortic Regurgitation
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: We had presented the data only for the participants who had an outcome at baseline and at 30 days (paired data).
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.
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=40 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=13 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Change in NYHA Class From Baseline to 30 Days
Improvement from BL NYHA II to 30days NYHA I
|
3 Participants
|
2 Participants
|
|
Change in NYHA Class From Baseline to 30 Days
Improvement from Baseline (BL) NYHA I to 30days
|
0 Participants
|
0 Participants
|
|
Change in NYHA Class From Baseline to 30 Days
Improvement from BL NYHA III to 30days NYHA I & II
|
25 Participants
|
8 Participants
|
|
Change in NYHA Class From Baseline to 30 Days
Improvement fromBL NYHA IV to 30days NYHA I,II,III
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 30 daysPopulation: We had presented the data only for the participants who had an outcome at baseline and at 30 days (paired data).
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.
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=39 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=9 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Change in Six Minute Walk Test From Baseline as Compared to 30 Days
|
46.3 Meter
Standard Deviation 94.7
|
6.0 Meter
Standard Deviation 87.3
|
SECONDARY outcome
Timeframe: 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).
Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=20 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=8 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Change in Effective Orifice Area From Baseline as Compared to 30 Days
|
1.1 cm2
Standard Deviation 0.3
|
1.0 cm2
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 7 daysPopulation: The number of participants who were available at that time point were included
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.
Outcome measures
| Measure |
Subclavian/Axillary Access Arm
n=45 Participants
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=16 Participants
Subjects who underwent Transaortic TAVR implant.
|
|---|---|---|
|
Number of Participants With Overall Acute Device Success
|
43 Participants
|
14 Participants
|
Adverse Events
Subclavian/Axillary Access Arm
Transaortic Access Arm
Serious adverse events
| Measure |
Subclavian/Axillary Access Arm
n=45 participants at risk
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 participants at risk
Subjects who underwent Transaortic TAVR implant
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.4%
2/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Blood and lymphatic system disorders
Chronic Lymphedema
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Atrial Fibrillation
|
4.4%
2/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Cardiac Arrhythmias
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Complete Heart Block
|
2.2%
1/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Heart Failure
|
2.2%
1/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Left Bundle Branch Block
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Pericardial Tamponade
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Sick Sinus Syndrome
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Gastrointestinal disorders
GI Bleed
|
4.4%
2/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
General disorders
Death of unknown cause
|
2.2%
1/45 • 1 Year
|
10.5%
2/19 • 1 Year
|
|
General disorders
Increasing Pain On Both Legs
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
General disorders
Oedema
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Infections and infestations
Fever
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Infections and infestations
Infection
|
0.00%
0/45 • 1 Year
|
15.8%
3/19 • 1 Year
|
|
Infections and infestations
Sepsis
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Injury, poisoning and procedural complications
Access Site Bleeding Event
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Injury, poisoning and procedural complications
Broken Arm Right Side
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Injury, poisoning and procedural complications
Broken Left Leg
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Injury, poisoning and procedural complications
Broken Leg With Hospitalization
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Injury, poisoning and procedural complications
Cardiac Perforation
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Injury, poisoning and procedural complications
Femoral Fracture
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Injury, poisoning and procedural complications
Re-Fracture Left Leg
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Injury, poisoning and procedural complications
Vascular Access Site and Access Related Complications
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Nervous system disorders
Stroke
|
8.9%
4/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/45 • 1 Year
|
15.8%
3/19 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/45 • 1 Year
|
10.5%
2/19 • 1 Year
|
|
Surgical and medical procedures
Device Embolization
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Surgical and medical procedures
Vessel Dissection
|
4.4%
2/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Vascular disorders
Bleeding
|
6.7%
3/45 • 1 Year
|
10.5%
2/19 • 1 Year
|
|
Cardiac disorders
Reduced Left Ventricular Function/ Subclinical Heart Failure
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
Other adverse events
| Measure |
Subclavian/Axillary Access Arm
n=45 participants at risk
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
|
Transaortic Access Arm
n=19 participants at risk
Subjects who underwent Transaortic TAVR implant
|
|---|---|---|
|
Injury, poisoning and procedural complications
Access Site Bleeding Event
|
4.4%
2/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Blood and lymphatic system disorders
Anemia
|
2.2%
1/45 • 1 Year
|
15.8%
3/19 • 1 Year
|
|
Cardiac disorders
Atrial Fibrillation
|
8.9%
4/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Vascular disorders
Bleeding
|
13.3%
6/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Complete Heart Block
|
4.4%
2/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Cardiac disorders
Congestive Heart Failure
|
4.4%
2/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Cardiac disorders
First Degree Heart Block
|
8.9%
4/45 • 1 Year
|
10.5%
2/19 • 1 Year
|
|
Vascular disorders
Hematoma
|
4.4%
2/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Vascular disorders
Hypotension
|
6.7%
3/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Cardiac disorders
Left Bundle Branch Block
|
20.0%
9/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Vascular disorders
Pseudoaneurysm
|
4.4%
2/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Cardiac disorders
Right Bundle Branch Block
|
4.4%
2/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Injury, poisoning and procedural complications
Vessel Dissection
|
11.1%
5/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Cardiac disorders
Accelerated Junctional Rhythm
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Nervous system disorders
Delirium
|
4.4%
2/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Cardiac disorders
Mild Congestive Heart Failure
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Pain Shoulder Left Access Site Myalgia
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Painful Left Arm (With Impaired Mobility)
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Injury, poisoning and procedural complications
Painful Right Groin (Diagnostic Site)
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Injury, poisoning and procedural complications
Pinched Nerve
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Cardiac disorders
Sinus Tachycardia
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Cardiac disorders
Supraventricular Extrasystole
|
2.2%
1/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Transient LBBB
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Cardiac disorders
Ventricular Extrasystole
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Bradycardia
|
2.2%
1/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Infections and infestations
Infection
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Renal and urinary disorders
Renal Insufficiency/Worsening Renal Function
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Left Anterior Fascicular Block
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Cardiac disorders
Angina Pectoris
|
4.4%
2/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
General disorders
Ankle Edema
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
General disorders
Chest Pain
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
General disorders
Dizziness And Short-Term Disorientation
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Nervous system disorders
Syncope Epileptic Insult
|
2.2%
1/45 • 1 Year
|
0.00%
0/19 • 1 Year
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/45 • 1 Year
|
5.3%
1/19 • 1 Year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60