Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
- Conditions
- Aortic Valve Stenosis
- Registration Number
- NCT02000115
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1242
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary Effectiveness Endpoint (Randomized IDE Cohort) One-year from randomization A composite of all-cause mortality or disabling stroke at one year.
Primary Safety Endpoint (Randomized IDE Cohort) 30 days from randomization 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.
Percentage of Patients With Major Vascular Complications (Primary Safety Endpoint- FlexNav Delivery System Study) 30 days from index procedure Valve Academic Research Consortium (VARC) 2- defined major vascular complications
- Secondary Outcome Measures
Name Time Method Percentage of Patients With Composite Safety Endpoint (Nested Valve-in-Valve Registry) 30 days from index procedure 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)Percentage of Patients With All-cause Mortality or Disabling Stroke (Nested Valve-in-Valve Registry) One year from index procedure A composite of all-cause mortality or disabling stroke at one year Anticipated completion data (2023)
Six-Minute Walk Test- Total Distance Walked (Randomized IDE Cohort) One year Six-minute walk distance at one year
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (Randomized IDE Cohort) One year Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year. Scale 0 to 100; with higher scores indicating better symptoms and physical functioning
Percentage of Patients With Severe Aortic Regurgitation (Randomized IDE Cohort) One year Severe aortic regurgitation (AR) at one year
Percentage of Patients With Moderate or Severe Aortic Regurgitation (Randomized IDE Cohort) One year Moderate or severe aortic regurgitation at one year
Related Research Topics
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Trial Locations
- Locations (70)
University Hospital - Univ. of Alabama at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
Banner - University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
John Muir Medical Center
🇺🇸Concord, California, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
USC University Hospital
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
Sutter Memorial Hospital
🇺🇸Sacramento, California, United States
Scroll for more (60 remaining)University Hospital - Univ. of Alabama at Birmingham (UAB)🇺🇸Birmingham, Alabama, United States