PORTICO-IDE
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
AI Description
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.
- Who can join
- adult, older adult
- Participants
- 1242
- Expected completion
- 2026-12
- Funded by
- industry
Conditions studied
Aortic Valve Stenosis
What is being tested
- DEVICE: Commercially available transcatheter aortic valve
- DEVICE: Portico transcatheter aortic valve
What it measures
- 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
- 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
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Abbott Northwestern Hospital
Minneapolis, MN
AdventHealth Orlando
Orlando, FL
Advocate Christ Medical Center (Oak Lawn)
Oak Lawn, IL
Albany Medical Center
Albany, NY
Allegheny General Hospital
Pittsburgh, PA
Ascension St. Vincent Heart Center
Carmel, IN
Banner – University Medical Center Phoenix
Phoenix, AZ
Baptist Memorial Hospital-Memphis
Memphis, TN
Barnes-Jewish Hospital
Saint Louis, MO
Baylor Scott & White The Heart Hospital – Plano
Plano, TX
Baylor St. Luke's Medical Center
Houston, TX
Catholic Medical Center
Manchester, NH
Cedars-Sinai Medical Center
Los Angeles, CA
Cleveland Clinic
Cleveland, OH
Delray Medical Center
Delray Beach, FL
Duke University Hospital
Durham, NC
ECU Health Medical Center
Greenville, NC
Emory University Hospital Midtown
Atlanta, GA
Hackensack University Medical Center
Hackensack, NJ
HCA Florida JFK Hospital
Atlantis, FL
Hoag Hospital (Newport Beach)
Newport Beach, CA
Hospital of the University of Pennsylvania
Philadelphia, PA
Houston Methodist Hospital
Houston, TX
Huntington Hospital
Pasadena, CA
Inova Fairfax Medical Campus
Falls Church, VA
John Muir Medical Center (Concord)
Concord, CA
Keck Hospital of USC
Los Angeles, CA
Lankenau Medical Center
Wynnewood, PA
Lenox Hill Hospital
New York, NY
Los Robles Regional Medical Center
Thousand Oaks, CA
Maimonides Medical Center
Brooklyn, NY
Massachusetts General Hospital
Boston, MA
Mayo Clinic (Rochester, Minnesota)
Rochester, MN
MedStar Washington Hospital Center
Washington, DC
Memorial Hermann-Texas Medical Center
Houston, TX
Mercy General Hospital (Sacramento)
Sacramento, CA
Mercy Heart Hospital Springfield
Springfield, MO
Mission Hospital (Asheville)
Asheville, NC
Morton Plant Hospital (Clearwater)
Clearwater, FL
Newark Beth Israel Medical Center
Newark, NJ
NewYork-Presbyterian Hospital
New York, NY
North Mississippi Medical Center-Tupelo
Tupelo, MS
Ochsner Medical Center – New Orleans
New Orleans, LA
Oklahoma Heart Hospital (Oklahoma City)
Oklahoma City, OK
Penn State Health Milton S. Hershey Medical Center
Hershey, PA
Saint Luke’s Hospital of Kansas City
Kansas City, MO
Sanford Heart Hospital (Sioux Falls)
Sioux Falls, SD
Scripps Memorial Hospital La Jolla
La Jolla, CA
Sentara Norfolk General Hospital
Norfolk, VA
St. Francis Hospital & Heart Center
Roslyn, NY
Stanford Health Care
Stanford, CA
Sutter Medical Center, Sacramento
Sacramento, CA
The Ohio State University Wexner Medical Center
Columbus, OH
TriStar Centennial Medical Center
Nashville, TN
UAB Hospital
Birmingham, AL
UM Health-Sparrow (Lansing)
Lansing, MI
University of Utah Health
Salt Lake City, UT
UPMC Harrisburg
Harrisburg, PA
UPMC Presbyterian Shadyside
Pittsburgh, PA
Registry entry updated 2025-07-20
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.