Last updated on July 2018

Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Brief description of study

The PORTICO clinical trial is a prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery methods.

Detailed Study Description

The PORTICO trial will include approximately 758 randomized subjects at up to 70 investigational sites. The study is powered to analyze the high risk cohort and extreme risk cohort together against a commercially available control for the primary safety and effectiveness endpoints. In addition, data for each cohort will be analyzed separately in a subgroup analysis.

A minimum of two (2) and up to three (3) roll-in patients per primary implanting physician will be allowed. These roll-in subjects will be added to a Roll-in Registry. In addition, up to 100 subjects may be enrolled in a Valve-in-Valve registry. Implanting physicians with prior Portico experience and with a minimum of 3 implants in the last 6 months will not be required to include roll-in patients.

Registry data will not be included in the randomized cohort analysis, but will be analyzed and presented separately.

The sponsor will submit a final clinical report for combined risk cohorts as enrollment and follow-up is completed according to the protocol.

Clinical Study Identifier: NCT02000115

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Oluseun Alli, M.D.

University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, AL United States
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Ashish Pershad, M.D.

Banner - University Medical Center Phoenix
Phoenix, AZ United States
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Gary Gershony, M.D.

John Muir Medical Center
Concord, CA United States
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Paul Teirstein, M.D.

Scripps Green Hospital
La Jolla, CA United States
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Vaughn Starnes, M.D.

USC University Hospital
Los Angeles, CA United States
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Raj Makkar, M.D.

Cedars-Sinai Medical Center
Los Angeles, CA United States
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Jorge Castellanos, M.D.

Hoag Memorial Hospital Presbyterian
Newport Beach, CA United States
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Michael Fishbein, M.D. Ph.D.

Stanford University Medical Center
Palo Alto, CA United States
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Azhil Durairaj, M.D.

Huntington Memorial Hospital
Pasadena, CA United States
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David Roberts, M.D.

Sutter Memorial Hospital
Sacramento, CA United States
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Frank Slachman, M.D.

Mercy General Hospital
Sacramento, CA United States
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Vishva Dev, M.D.

Los Robles Regional Medical Center
Thousand Oaks, CA United States
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Ron Waksman, M.D.

Washington Hospital Center
Washington, WA United States
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Marcos Nores, M.D.

JFK Medical Center
Atlantis, FL United States
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Joshua Rovin, M.D.

Morton Plant Valve Clinic
Clearwater, FL United States
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Brijeshwar Maini, M.D.

Delray Medical Center
Delray Beach, FL United States
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Andrew Taussig, M.D.

Florida Hospital Orlando
Orlando, FL United States
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Vinod Thourani, M.D.

Emory University Hospital
Atlanta, GA United States
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Antone Tatooles, M.D.

Advocate Christ Medical Center
Oak Lawn, IL United States
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David Heimansohn, M.D.

St. Vincent Hospital
Indianapolis, IN United States
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Bart Jenson, M.D.

Iowa Heart Center
West Des Moines, IA United States
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Brett Grizzell, M.D.

Cardiovascular Research Institute of Kansas
Wichita, KS United States
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Stephen Ramee, M.D.

Ochsner Medical Center
New Orleans, LA United States
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Ignacio Inglessis, M.D.

Massachusetts General Hospital
Boston, MA United States
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Gaurav Dhar, M.D.

Sparrow Clinical Research Institute
Lansing, MI United States
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Paul Sorajja, M.D.

Abbott Northwestern Hospital
Minneapolis, MN United States
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Angie Roach

Mayo Clinic
Rochester, MN United States
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David Talton, M.D.

North Mississippi Medical Center
Tupelo, MS United States
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Adnan Chhatriwalla, M.D.

St. Luke's Hospital
Kansas City, MO United States
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Robert Merritt, M.D.

Mercy Hospital Springfield
Springfield, MO United States
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James Flynn, M.D.

Catholic Medical Center
Manchester, NH United States
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Elie Elmann, M.D.

Hackensack University Medical Center
Hackensack, NJ United States
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Marc Cohen, M.D.

Newark Beth Israel Medical Center
Newark, NJ United States
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Francis Ferdinand, M.D.

Albany Medical Center
Albany, NY United States
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Robert Frankel, M.D.

Maimonides Medical Center
Brooklyn, NY United States
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Richard Schwartz, D.O.

Winthrop University Hospital
Mineola, NY United States
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Shing-Chiu Wong, M.D.

New York Presbyterian Hospital / Cornell University
New York, NY United States
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Angie Roach

Lenox Hill Hospital
New York, NY United States
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Newell Robinson, M.D.

St. Francis Hospital
Roslyn, NY United States
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Mark Groh, M.D.

Mission Health and Hospitals
Asheville, NC United States
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John Vavalle, M.D.

University of North Carolina at Chapel Hill
Chapel Hill, NC United States
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Jeffrey Gaca, M.D.

Duke University Medical Center
Durham, NC United States
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Andy Kiser, M.D.

East Carolina Heart Institute
Greenville, NC United States
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Lars Svensson, M.D. Ph.D.

The Cleveland Clinic Foundation
Cleveland, OH United States
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Scott Lilly, M.D.

Ohio State University
Columbus, OH United States
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Robert Bodenhamer, M.D.

Oklahoma Heart Hospital
Oklahoma City, OK United States
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Hemal Gada, M.D.

Pinnacle Health System
Harrisburg, PA United States
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Nimesh Desai, M.D. Ph.D.

Hospital of the University of Pennsylvania
Philadelphia, PA United States
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Ramzi Khalil, M.D.

Allegheny Singer Research Institute
Pittsburgh, PA United States
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Joon Sup Lee, M.D.

University of Pittsburgh Medical Center
Pittsburgh, PA United States
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Roberto Rodriguez, M.D.

Main Line Health Center/Lankenau Hospital
Wynnewood, PA United States
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Thomasz Stys, M.D.

Sanford USD Medical Center
Sioux Falls, SD United States
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Edward Garrett, M.D.

Baptist Memorial Hospital
Memphis, TN United States
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John Riddick, M.D.

Centennial Medical Center
Nashville, TN United States
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Frank Zidar, M.D.

Heart Hospital of Austin
Austin, TX United States
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Guilherme Silva, M.D.

CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, TX United States
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Igor Gregoric, M.D.

Memorial Hermann Hospital
Houston, TX United States
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Michael Reardon, M.D.

The Methodist Hospital
Houston, TX United States
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William Brinkman, M.D.

The Heart Hospital Baylor Plano
Plano, TX United States
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Anwar Tandar, M.D.

University of Utah Hospital
Salt Lake City, UT United States
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Bryan Raybuck, M.D.

Inova Fairfax Hospital
Falls Church, VA United States
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Paul Mahoney, M.D.

Sentara Norfolk General Hospital
Norfolk, VA United States
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Martin Ng, M.D.

Macquarie University Hospital
Sydney, Australia
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Darren Walters, M.D.

The Prince Charles Hospital
Chermside, Australia
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Stephen Worthley, MBBS PhD

Royal Adelaide Hospital
Adelaide, Australia
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Tony Walton, M.D.

The Alfred Hospital
Melbourne, Australia
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Gerald Yong, M.D.

Fiona Stanley Hospital
Murdoch, Australia
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Alan Zajarias, M.D.

Barnes-Jewish Hospital
Saint Louis, MO United States
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Mark Kozak, M.D.

Penn State Milton S. Hershey Medical Center
Hershey, PA United States
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Ming Zhang, M.D.

Swedish Medical Center
Seattle, WA United States
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