Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Not Applicable

Active, not recruiting

Conditions: Aortic Valve Stenosis

Interventions: Device: Portico transcatheter aortic valve
Device: Commercially available transcatheter aortic valve

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized IDE Cohort, Portico Valve	Portico transcatheter aortic valve	Portico transcatheter aortic valve and Portico delivery system. Status: ACTIVE, NOT ENROLLING.
Randomized IDE Cohort, CAV	Commercially available transcatheter aortic valve	Any FDA approved, commercially-available transcatheter aortic valve (CAV). Status: ACTIVE, NOT ENROLLING.
Nested Valve-in-Valve Registry	Portico transcatheter aortic valve	Subjects who have documented failed aortic surgical valve prosthesis and are deemed eligible to receive a transcatheter Portico valve Status: ACTIVE, ENROLLING.
FlexNav Delivery System Study	Portico transcatheter aortic valve	Portico transcatheter aortic valve and FlexNav delivery system Status: ACTIVE, NOT ENROLLING

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)
Percentage of Patients With Moderate or Severe Aortic Regurgitation (Randomized IDE Cohort)	One year	Moderate or severe aortic regurgitation at one year
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

Trial Locations

Locations (70): University Hospital - Univ. of Alabama at Birmingham (UAB)
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Birmingham, Alabama, United States
Banner - University Medical Center Phoenix
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Phoenix, Arizona, United States
John Muir Medical Center
🇺🇸
Concord, California, United States
Scripps Green Hospital
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La Jolla, California, United States
USC University Hospital
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Los Angeles, California, United States
Mercy General Hospital
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Sacramento, California, United States
Los Robles Regional Medical Center
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Thousand Oaks, California, United States
Pinnacle Health System
🇺🇸
Harrisburg, Pennsylvania, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
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Newport Beach, California, United States
Stanford University Medical Center
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Palo Alto, California, United States
Huntington Memorial Hospital
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Pasadena, California, United States
Sutter Memorial Hospital
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Sacramento, California, United States
Washington Hospital Center
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Washington, District of Columbia, United States
JFK Medical Center
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Atlantis, Florida, United States
Morton Plant Valve Clinic
🇺🇸
Clearwater, Florida, United States
Delray Medical Center
🇺🇸
Delray Beach, Florida, United States
Florida Hospital Orlando
🇺🇸
Orlando, Florida, United States
Emory University Hospital
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Atlanta, Georgia, United States
Advocate Christ Medical Center
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Oak Lawn, Illinois, United States
St. Vincent Hospital
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Indianapolis, Indiana, United States
Iowa Heart Center
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West Des Moines, Iowa, United States
Cardiovascular Research Institute of Kansas
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Wichita, Kansas, United States
Ochsner Medical Center
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New Orleans, Louisiana, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
Sparrow Clinical Research Institute
🇺🇸
Lansing, Michigan, United States
Abbott Northwestern Hospital
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Minneapolis, Minnesota, United States
Mayo Clinic
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Rochester, Minnesota, United States
North Mississippi Medical Center
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Tupelo, Mississippi, United States
St. Luke's Hospital
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Kansas City, Missouri, United States
Barnes-Jewish Hospital
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Saint Louis, Missouri, United States
Mercy Hospital Springfield
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Springfield, Missouri, United States
Catholic Medical Center
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Manchester, New Hampshire, United States
Hackensack University Medical Center
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Hackensack, New Jersey, United States
Newark Beth Israel Medical Center
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Newark, New Jersey, United States
Albany Medical Center
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Albany, New York, United States
Maimonides Medical Center
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Brooklyn, New York, United States
Winthrop University Hospital
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Mineola, New York, United States
New York Presbyterian Hospital / Cornell University
🇺🇸
New York, New York, United States
Lenox Hill Hospital
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New York, New York, United States
St. Francis Hospital
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Roslyn, New York, United States
Mission Health and Hospitals
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Asheville, North Carolina, United States
University of North Carolina at Chapel Hill
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Chapel Hill, North Carolina, United States
Duke University Medical Center
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Durham, North Carolina, United States
East Carolina Heart Institute
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Greenville, North Carolina, United States
The Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Ohio State University
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Columbus, Ohio, United States
Oklahoma Heart Hospital
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Oklahoma City, Oklahoma, United States
Penn State Milton S. Hershey Medical Center
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Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, United States
Allegheny Singer Research Institute
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States
Main Line Health Center/Lankenau Hospital
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Wynnewood, Pennsylvania, United States
Sanford USD Medical Center
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Sioux Falls, South Dakota, United States
Baptist Memorial Hospital
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Memphis, Tennessee, United States
Centennial Medical Center
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Nashville, Tennessee, United States
Heart Hospital of Austin
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Austin, Texas, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center
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Houston, Texas, United States
Memorial Hermann Hospital
🇺🇸
Houston, Texas, United States
The Methodist Hospital
🇺🇸
Houston, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸
Plano, Texas, United States
University of Utah Hospital
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Salt Lake City, Utah, United States
Inova Fairfax Hospital
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Falls Church, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
Swedish Medical Center
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Seattle, Washington, United States
Macquarie University Hospital
🇦🇺
Sydney, New South Wales, Australia
The Prince Charles Hospital
🇦🇺
Chermside, Queensland, Australia
Royal Adelaide Hospital
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Adelaide, South Australia, Australia
The Alfred Hospital
🇦🇺
Melbourne, Victoria, Australia
Fiona Stanley Hospital
🇦🇺
Murdoch, Western Australia, Australia