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Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access (Portico ALT)

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ClinicalTrials.gov Identifier: NCT03056573
Recruitment Status : Completed
First Posted : February 17, 2017
Results First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Aortic Valve Stenosis
Interventions Device: Transaortic TAVR Implant
Device: Subclavian /Axillary TAVR implant
Enrollment 64
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.
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site. Subjects who underwent Transaortic TAVR implant.
Period Title: Overall Study
Started 45 19
Completed 40 14
Not Completed 5 5
Reason Not Completed
Death             2             4
Withdrawal by Subject             2             0
Lost to Follow-up             1             1
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Arm Total
Hide Arm/Group Description Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site. Subjects who underwent Transaortic TAVR implant. Total of all reporting groups
Overall Number of Baseline Participants 45 19 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 19 participants 64 participants
81.7  (5.9) 77.1  (7.2) 80.3  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 19 participants 64 participants
Female
26
  57.8%
10
  52.6%
36
  56.3%
Male
19
  42.2%
9
  47.4%
28
  43.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 19 participants 64 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
45
 100.0%
19
 100.0%
64
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 19 participants 64 participants
Italy
14
  31.1%
3
  15.8%
17
  26.6%
Switzerland
2
   4.4%
0
   0.0%
2
   3.1%
Germany
5
  11.1%
3
  15.8%
8
  12.5%
Denmark
1
   2.2%
0
   0.0%
1
   1.6%
Netherlands
23
  51.1%
13
  68.4%
36
  56.3%
1.Primary Outcome
Title Number of Participants With Major Vascular Complications
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.4%
1
   5.3%
2.Secondary Outcome
Title Number of All- Cause Mortality
Hide Description [Not Specified]
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.2%
2
  10.5%
3.Secondary Outcome
Title Number of All- Cause Mortality
Hide Description [Not Specified]
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.4%
4
  21.1%
4.Secondary Outcome
Title Cardiovascular Mortality
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
  10.5%
5.Secondary Outcome
Title Cardiovascular Mortality
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.2%
4
  21.1%
6.Secondary Outcome
Title Number of Participants With Disabling Stroke
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.2%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Disabling Stroke
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.2%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With Non-disabling Strokes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
4
   8.9%
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Non-disabling Strokes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
4
   8.9%
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Life Threatening Bleeding Requiring Transfusion
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.4%
2
  10.5%
11.Secondary Outcome
Title Number of Participants With Life Threatening Bleeding Requiring Transfusion
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.4%
2
  10.5%
12.Secondary Outcome
Title Number of Participants With Acute Kidney Injury Requiring Dialysis
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Acute Kidney Injury Requiring Dialysis
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
5
  11.1%
0
   0.0%
15.Secondary Outcome
Title Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 19
Measure Type: Count of Participants
Unit of Measure: Participants
5
  11.1%
0
   0.0%
16.Secondary Outcome
Title Number of Participants With Moderate and Severe Aortic Regurgitation
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who were available at that time point were included
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 28 13
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.6%
1
   7.7%
17.Secondary Outcome
Title Change in NYHA Class From Baseline to 30 Days
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
We had presented the data only for the participants who had an outcome at baseline and at 30 days (paired data).
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 40 13
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement from Baseline (BL) NYHA I to 30days
0
   0.0%
0
   0.0%
Improvement from BL NYHA II to 30days NYHA I
3
   7.5%
2
  15.4%
Improvement from BL NYHA III to 30days NYHA I & II
25
  62.5%
8
  61.5%
Improvement fromBL NYHA IV to 30days NYHA I,II,III
3
   7.5%
0
   0.0%
18.Secondary Outcome
Title Change in Six Minute Walk Test From Baseline as Compared to 30 Days
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
We had presented the data only for the participants who had an outcome at baseline and at 30 days (paired data).
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 39 9
Mean (Standard Deviation)
Unit of Measure: Meter
46.3  (94.7) 6.0  (87.3)
19.Secondary Outcome
Title Change in Effective Orifice Area From Baseline as Compared to 30 Days
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
We had presented the data only for the participants who had an outcome at baseline and at 30 days (paired data).
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 20 8
Mean (Standard Deviation)
Unit of Measure: cm2
1.1  (0.3) 1.0  (0.3)
20.Secondary Outcome
Title Number of Participants With Overall Acute Device Success
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who were available at that time point were included
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description:
Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site.
Subjects who underwent Transaortic TAVR implant.
Overall Number of Participants Analyzed 45 16
Measure Type: Count of Participants
Unit of Measure: Participants
43
  95.6%
14
  87.5%
Time Frame 1 Year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subclavian/Axillary Access Arm Transaortic Access Arm
Hide Arm/Group Description Subjects who underwent TAVR with the Portico THV via the subclavian or axillary alternative access site. Subjects who underwent Transaortic TAVR implant
All-Cause Mortality
Subclavian/Axillary Access Arm Transaortic Access Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   2/45 (4.44%)   4/19 (21.05%) 
Hide Serious Adverse Events
Subclavian/Axillary Access Arm Transaortic Access Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   21/45 (46.67%)   15/19 (78.95%) 
Blood and lymphatic system disorders     
Anemia  1  2/45 (4.44%)  1/19 (5.26%) 
Chronic Lymphedema  1  1/45 (2.22%)  0/19 (0.00%) 
Cardiac disorders     
Angina Pectoris  1  0/45 (0.00%)  1/19 (5.26%) 
Atrial Fibrillation  1  2/45 (4.44%)  1/19 (5.26%) 
Cardiac Arrhythmias  1  0/45 (0.00%)  1/19 (5.26%) 
Complete Heart Block  1  1/45 (2.22%)  1/19 (5.26%) 
Heart Failure  1  1/45 (2.22%)  1/19 (5.26%) 
Left Bundle Branch Block  1  1/45 (2.22%)  0/19 (0.00%) 
Myocardial Infarction  1  0/45 (0.00%)  1/19 (5.26%) 
Pericardial Effusion  1  0/45 (0.00%)  1/19 (5.26%) 
Pericardial Tamponade  1  0/45 (0.00%)  1/19 (5.26%) 
Sick Sinus Syndrome  1  1/45 (2.22%)  0/19 (0.00%) 
Reduced Left Ventricular Function/ Subclinical Heart Failure  1  1/45 (2.22%)  0/19 (0.00%) 
Gastrointestinal disorders     
GI Bleed  1  2/45 (4.44%)  0/19 (0.00%) 
General disorders     
Death of unknown cause  1  1/45 (2.22%)  2/19 (10.53%) 
Increasing Pain On Both Legs  1  1/45 (2.22%)  0/19 (0.00%) 
Oedema  1  0/45 (0.00%)  1/19 (5.26%) 
Infections and infestations     
Fever  1  0/45 (0.00%)  1/19 (5.26%) 
Infection  1  0/45 (0.00%)  3/19 (15.79%) 
Sepsis  1  1/45 (2.22%)  0/19 (0.00%) 
Injury, poisoning and procedural complications     
Access Site Bleeding Event  1  1/45 (2.22%)  0/19 (0.00%) 
Broken Arm Right Side  1  1/45 (2.22%)  0/19 (0.00%) 
Broken Left Leg  1  1/45 (2.22%)  0/19 (0.00%) 
Broken Leg With Hospitalization  1  1/45 (2.22%)  0/19 (0.00%) 
Cardiac Perforation  1  0/45 (0.00%)  1/19 (5.26%) 
Femoral Fracture  1  1/45 (2.22%)  0/19 (0.00%) 
Re-Fracture Left Leg  1  1/45 (2.22%)  0/19 (0.00%) 
Vascular Access Site and Access Related Complications  1  1/45 (2.22%)  0/19 (0.00%) 
Nervous system disorders     
Stroke  1  4/45 (8.89%)  0/19 (0.00%) 
Transient Ischemic Attack (TIA)  1  1/45 (2.22%)  0/19 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury  1  0/45 (0.00%)  1/19 (5.26%) 
Renal Failure  1  0/45 (0.00%)  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration Pneumonia  1  1/45 (2.22%)  0/19 (0.00%) 
Dyspnea  1  0/45 (0.00%)  1/19 (5.26%) 
Pleural Effusion  1  0/45 (0.00%)  3/19 (15.79%) 
Pneumothorax  1  0/45 (0.00%)  2/19 (10.53%) 
Surgical and medical procedures     
Device Embolization  1  1/45 (2.22%)  0/19 (0.00%) 
Vessel Dissection  1  2/45 (4.44%)  0/19 (0.00%) 
Vascular disorders     
Bleeding  1  3/45 (6.67%)  2/19 (10.53%) 
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subclavian/Axillary Access Arm Transaortic Access Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   30/45 (66.67%)   9/19 (47.37%) 
Blood and lymphatic system disorders     
Anemia  1  1/45 (2.22%)  3/19 (15.79%) 
Cardiac disorders     
Atrial Fibrillation  1  4/45 (8.89%)  1/19 (5.26%) 
Complete Heart Block  1  2/45 (4.44%)  0/19 (0.00%) 
Congestive Heart Failure  1  2/45 (4.44%)  0/19 (0.00%) 
First Degree Heart Block  1  4/45 (8.89%)  2/19 (10.53%) 
Left Bundle Branch Block  1  9/45 (20.00%)  1/19 (5.26%) 
Right Bundle Branch Block  1  2/45 (4.44%)  0/19 (0.00%) 
Accelerated Junctional Rhythm  1  1/45 (2.22%)  0/19 (0.00%) 
Mild Congestive Heart Failure  1  1/45 (2.22%)  0/19 (0.00%) 
Sinus Tachycardia  1  1/45 (2.22%)  0/19 (0.00%) 
Supraventricular Extrasystole  1  1/45 (2.22%)  1/19 (5.26%) 
Transient LBBB  1  1/45 (2.22%)  0/19 (0.00%) 
Ventricular Extrasystole  1  1/45 (2.22%)  0/19 (0.00%) 
Atrial Flutter  1  0/45 (0.00%)  1/19 (5.26%) 
Bradycardia  1  1/45 (2.22%)  1/19 (5.26%) 
Ventricular Fibrillation  1  0/45 (0.00%)  1/19 (5.26%) 
Left Anterior Fascicular Block  1  0/45 (0.00%)  1/19 (5.26%) 
Angina Pectoris  1  2/45 (4.44%)  0/19 (0.00%) 
Aortic Valve Stenosis  1  0/45 (0.00%)  1/19 (5.26%) 
General disorders     
Ankle Edema  1  1/45 (2.22%)  0/19 (0.00%) 
Chest Pain  1  1/45 (2.22%)  0/19 (0.00%) 
Dizziness And Short-Term Disorientation  1  1/45 (2.22%)  0/19 (0.00%) 
Infections and infestations     
Infection  1  0/45 (0.00%)  1/19 (5.26%) 
Injury, poisoning and procedural complications     
Access Site Bleeding Event  1  2/45 (4.44%)  0/19 (0.00%) 
Vessel Dissection  1  5/45 (11.11%)  0/19 (0.00%) 
Painful Right Groin (Diagnostic Site)  1  1/45 (2.22%)  0/19 (0.00%) 
Pinched Nerve  1  1/45 (2.22%)  0/19 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pain Shoulder Left Access Site Myalgia  1  1/45 (2.22%)  0/19 (0.00%) 
Painful Left Arm (With Impaired Mobility)  1  1/45 (2.22%)  0/19 (0.00%) 
Nervous system disorders     
Delirium  1  2/45 (4.44%)  0/19 (0.00%) 
Syncope Epileptic Insult  1  1/45 (2.22%)  0/19 (0.00%) 
Renal and urinary disorders     
Renal Insufficiency/Worsening Renal Function  1  0/45 (0.00%)  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Edema  1  1/45 (2.22%)  0/19 (0.00%) 
Dyspnea  1  0/45 (0.00%)  1/19 (5.26%) 
Vascular disorders     
Bleeding  1  6/45 (13.33%)  1/19 (5.26%) 
Hematoma  1  2/45 (4.44%)  0/19 (0.00%) 
Hypotension  1  3/45 (6.67%)  0/19 (0.00%) 
Pseudoaneurysm  1  2/45 (4.44%)  0/19 (0.00%) 
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Angelic Roach, Clinical Program Director
Organization: Abbott
Phone: +16517563379
EMail: angelic.roach@abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03056573    
Other Study ID Numbers: SJM-CIP-10144
First Submitted: January 31, 2017
First Posted: February 17, 2017
Results First Submitted: January 9, 2020
Results First Posted: March 17, 2020
Last Update Posted: March 17, 2020