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
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Sponsor:
Abbott Medical Devices
Information provided by (Responsible Party):
Abbott Medical Devices
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Study Type | Interventional |
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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 |
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. |
Arm/Group Title | Subclavian/Axillary Access Arm | Transaortic Access Arm |
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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 |
Baseline Characteristics
Arm/Group Title | Subclavian/Axillary Access Arm | Transaortic Arm | Total | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 45 participants | 19 participants | 64 participants | |
Female |
26 57.8%
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10 52.6%
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36 56.3%
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Male |
19 42.2%
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9 47.4%
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28 43.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 45 participants | 19 participants | 64 participants | |
Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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Not Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
45 100.0%
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19 100.0%
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64 100.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 45 participants | 19 participants | 64 participants |
Italy |
14 31.1%
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3 15.8%
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17 26.6%
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Switzerland |
2 4.4%
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0 0.0%
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2 3.1%
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Germany |
5 11.1%
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3 15.8%
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8 12.5%
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Denmark |
1 2.2%
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0 0.0%
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1 1.6%
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Netherlands |
23 51.1%
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13 68.4%
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36 56.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Angelic Roach, Clinical Program Director |
Organization: | Abbott |
Phone: | +16517563379 |
EMail: | angelic.roach@abbott.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |