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Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic aortic stenosis via transfemoral and alternative delivery methods in high risk and extreme risk patients.
Study details:
The PORTICO pivotal IDE trial will include a randomized cohort of 750 subjects enrolled at up to 70 investigational sites in the United States and Australia. Patients will be randomized (1:1) to receive the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) or any FDA-approved, commercially-available Transcatheter Aortic Valve Replacement (TAVR) System. The randomized cohort will be tested for two co-primary endpoints at 30 days (primary safety endpoint) and 1 year (primary effectiveness endpoint).
At the time of the primary randomized cohort analysis, the risk cohorts will be combined and analysis will be conducted on the intention-to-treat (n=750) population. The FlexNav Delivery System study will be conducted as a separate arm of the PORTICO IDE trial and will include up to 200 high or extreme risk subjects; including a minimum of 100 analysis subjects. The study will characterize the safety of the next-generation Portico Delivery System ("FlexNav™ Delivery System").
The primary analysis cohort will include FlexNav analysis subjects. The IDE Valve-in-Valve registry will enroll up to 100 high or extreme risk subjects with a failed surgical bioprosthesis who are eligible to receive a Portico Transcatheter Heart Valve. All subjects enrolled in the PORTICO pivotal IDE trial will undergo follow-up at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, 12-months and then annually through 5-years.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 21 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2014-05-01
Primary completion: 2019-10-01
Study completion finish: 2025-07-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT02000115
Intervention or treatment
DEVICE: Portico transcatheter aortic valve
DEVICE: Commercially available transcatheter aortic valve
Conditions
- • Aortic Valve Stenosis
Find a site
Closest Location:
The Prince Charles Hospital
Research sites nearby
Select from list below to view details:
The Prince Charles Hospital
Chermside, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Randomized IDE Cohort, Portico Valve
| DEVICE: Portico transcatheter aortic valve
|
ACTIVE_COMPARATOR: Randomized IDE Cohort, CAV
| DEVICE: Commercially available transcatheter aortic valve
|
EXPERIMENTAL: Nested Valve-in-Valve Registry
| DEVICE: Portico transcatheter aortic valve
|
EXPERIMENTAL: FlexNav Delivery System Study
| DEVICE: Portico transcatheter aortic valve
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Primary Effectiveness Endpoint (Randomized IDE Cohort) | A composite of all-cause mortality or disabling stroke at one year. | One-year from randomization |
Primary Safety Endpoint (Randomized IDE Cohort) | Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days. | 30 days from randomization |
Percentage of Patients With Major Vascular Complications (Primary Safety Endpoint- FlexNav Delivery System Study) | Valve Academic Research Consortium (VARC) 2- defined major vascular complications | 30 days from index procedure |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Percentage of Patients With Severe Aortic Regurgitation (Randomized IDE Cohort) | Severe aortic regurgitation (AR) at one year | One year |
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (Randomized IDE Cohort) | Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year. Scale 0 to 100; with higher scores indicating better symptoms and physical functioning | One year |
Percentage of Patients With Moderate or Severe Aortic Regurgitation (Randomized IDE Cohort) | Moderate or severe aortic regurgitation at one year | One year |
Six-Minute Walk Test- Total Distance Walked (Randomized IDE Cohort) | Six-minute walk distance at one year | One year |
Percentage of Patients With Composite Safety Endpoint (Nested Valve-in-Valve Registry) | Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days from index procedure. Anticipated completion date (2022) | 30 days from index procedure |
Percentage of Patients With All-cause Mortality or Disabling Stroke (Nested Valve-in-Valve Registry) | A composite of all-cause mortality or disabling stroke at one year Anticipated completion data (2023) | One year from index procedure |
Frequently Asked Questions
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