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Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO IDE)

This study is currently recruiting participants.
Verified March 2017 by St. Jude Medical
Sponsor:
ClinicalTrials.gov Identifier:
NCT02000115
First Posted: December 3, 2013
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
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.

Condition Intervention
Aortic Valve Stenosis Device: Portico transcatheter aortic valve Device: Commercially available transcatheter aortic valve

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Primary Effectiveness Endpoint [ Time Frame: One year ]
    A composite of all-cause mortality or disabling stroke at one year.

  • Primary Safety Endpoint [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures:
  • Severe aortic regurgitation [ Time Frame: One year ]
    Severe aortic regurgitation (AR) at one year

  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: One year ]
    Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year

  • Moderate or severe aortic regurgitation [ Time Frame: One year ]
    Moderate or severe aortic regurgitation at one year

  • Six minute walk [ Time Frame: One year ]
    Six minute walk at one year


Estimated Enrollment: 758
Study Start Date: May 2014
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Portico
Portico transcatheter aortic valve
Device: Portico transcatheter aortic valve
St. Jude Medical transcatheter Portico aortic valve
Active Comparator: Commercially Available Valve
Commercially available transcatheter aortic valve
Device: Commercially available transcatheter aortic valve
Commercially available transcatheter aortic valve

Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

High Risk Cohort:

All candidates for the High Risk Cohort of this study must meet all the following inclusion criteria:

  1. Subjects must have co-morbidities such that the surgeon and cardiologist Co-Investigators concur that the predicted risk of operative mortality is ≥15% or a minimum STS score of 8%. A candidate who does not meet the STS score criteria of ≥ 8% can be included in the study if a peer review by at least two surgeons concludes and documents that the patient's predicted risk of operative mortality is ≥15%. The surgeon's assessment of operative comorbidities not captured by the STS score must be documented in the study case report form as well as in the patient medical record.
  2. Subject is 21 years of age or older at the time of consent.
  3. Subject has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or Doppler Velocity Index <0.25 and an initial aortic valve area (AVA) of ≤ 1.0 cm2 (indexed EOA ≤ 0.6 cm2/m2). (Qualifying AVA baseline measurement must be within 60 days prior to informed consent).
  4. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
  5. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  6. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
  7. Subject's aortic annulus is 19-27mm diameter as measured by CT conducted within 12 months prior to informed consent. Note: if CT is contraindicated and/or not possible to be obtained for certain subjects, a 3D echo and non-contrast CT of chest and abdomen/pelvis may be accepted if approved by the subject selection committee.

Extreme Risk Cohort:

All candidates for the Extreme Risk Cohort of this study must meet # 2, 3, 4, 5, 6, 7 of the above criteria, and 1. The subject, after formal consults by a cardiologist and two cardiovascular surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%. The surgeons' consult notes shall specify the medical or anatomic factors leading to that conclusion and include a printout of the calculation of the STS score to additionally identify the risks in these patients.

All Candidates:

Additionally, all candidates for the study must meet the following inclusion criteria for the TAVR Leaflet Motion Sub-study, until the minimum sub-study sample size has been achieved:

1. Be willing and able to undergo, at both 30-days and 6-months post-implant, a Multi-Slice Computed Tomography (MSCT) scan (or TEE, if medically or technically contraindicated for an MSCT) of the heart and cardiac structures.

Exclusion Criteria:

High and Extreme Risk Cohort:

Candidates will be excluded from the study if any of the following conditions are present:

  1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.
  2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified as verified by echocardiography.
  3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).
  4. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.
  5. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the LVOT, severe (greater than 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise. Subjects with pre-existing surgical bioprosthetic aortic heart valve should be considered for the Valve-in-Valve registry.
  6. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 mg/dL), thrombocytopenia (platelet count <50,000 cells/mm³).
  7. History of bleeding diathesis or coagulopathy.
  8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
  9. Untreated clinically significant coronary artery disease requiring revascularization.
  10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
  11. Need for emergency surgery for any reason.
  12. Hypertrophic cardiomyopathy with or without obstruction (HOCM).
  13. Severe ventricular dysfunction with LVEF <20% as measured by resting echocardiogram.
  14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  15. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure.
  16. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be adequately premedicated.
  17. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
  18. Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis.
  19. Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions.
  20. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable for transfemoral patients only).
  21. Native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging.
  22. Aortic root angulation > 70° (applicable for transfemoral patients only).
  23. Currently participating in an investigational drug or device study.
  24. Active bacterial endocarditis within 6 months prior to the index procedure.
  25. Bulky calcified aortic valve leaflets in close proximity to coronary ostia.
  26. Non-calcified aortic annulus
  27. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath such as severe obstructive calcification, or severe tortuosity (applicable for transfemoral patients only).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000115


Contacts
Contact: Angie Roach aroach@sjm.com

  Hide Study Locations
Locations
United States, Alabama
University Hospital - Univ. of Alabama at Birmingham (UAB) Recruiting
Birmingham, Alabama, United States, 35249
Principal Investigator: Mark Sasse, M.D.         
Principal Investigator: Oluseun Alli, M.D.         
United States, Arizona
Banner - University Medical Center Phoenix Recruiting
Phoenix, Arizona, United States, 85006
Principal Investigator: Ashish Pershad, M.D.         
United States, California
John Muir Medical Center Recruiting
Concord, California, United States, 94520
Principal Investigator: Gary Gershony, M.D.         
Scripps Green Hospital Recruiting
La Jolla, California, United States, 92037
Principal Investigator: Paul Teirstein, M.D.         
USC University Hospital Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Vaughn Starnes, M.D.         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Raj Makkar, M.D.         
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92663
Principal Investigator: Anthony Caffarelli, M.D.         
Principal Investigator: Jorge Castellanos, M.D.         
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94305
Principal Investigator: William Fearon, M.D.         
Principal Investigator: Michael Fishbein, M.D. Ph.D.         
Huntington Memorial Hospital Recruiting
Pasadena, California, United States, 91109
Principal Investigator: Azhil Durairaj, M.D.         
Sutter Memorial Hospital Recruiting
Sacramento, California, United States, 95816
Principal Investigator: David Roberts, M.D.         
Mercy General Hospital Recruiting
Sacramento, California, United States, 95819
Principal Investigator: Joseph Kozina, M.D.         
Principal Investigator: Frank Slachman, M.D.         
Los Robles Regional Medical Center Recruiting
Thousand Oaks, California, United States, 91360
Principal Investigator: Gregory Fontana, M.D.         
Principal Investigator: Vishva Dev, M.D.         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Paul Corso, M.D.         
Principal Investigator: Ron Waksman, M.D.         
United States, Florida
JFK Medical Center Recruiting
Atlantis, Florida, United States, 33462
Principal Investigator: Mark Rothenberg, M.D.         
Principal Investigator: Marcos Nores, M.D.         
Morton Plant Valve Clinic Recruiting
Clearwater, Florida, United States, 33756
Principal Investigator: Lang Lin, M.D.         
Principal Investigator: Joshua Rovin, M.D.         
Delray Medical Center Not yet recruiting
Delray Beach, Florida, United States, 33484
Principal Investigator: Brijeshwar Maini, M.D.         
St. Vincent's Medical Center Recruiting
Jacksonville, Florida, United States, 32204
Principal Investigator: Mark Mostovych, M.D.         
Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803
Principal Investigator: Andrew Taussig, M.D.         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30308
Principal Investigator: Vinod Thourani, M.D.         
United States, Illinois
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60653
Principal Investigator: Ravi Ramana, M.D.         
Principal Investigator: Antone Tatooles, M.D.         
United States, Indiana
IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Anjan Sinha, M.D.         
Principal Investigator: Joel Corvera, M.D.         
St. Vincent Hospital Recruiting
Indianapolis, Indiana, United States, 46290
Principal Investigator: James Hermiller, M.D.         
Principal Investigator: David Heimansohn, M.D.         
United States, Iowa
Iowa Heart Center Recruiting
West Des Moines, Iowa, United States, 50266
Principal Investigator: Atul Chawla, M.D.         
Principal Investigator: Bart Jenson, M.D.         
United States, Kansas
Cardiovascular Research Institute of Kansas Recruiting
Wichita, Kansas, United States, 67226
Principal Investigator: Bassem Chehab, M.D.         
Principal Investigator: Brett Grizzell, M.D.         
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Principal Investigator: Stephen Ramee, M.D.         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Ignacio Inglessis, M.D.         
United States, Michigan
Sparrow Clinical Research Institute Recruiting
Lansing, Michigan, United States, 48912
Principal Investigator: Norbert Baumgartner, M.D.         
Principal Investigator: Gaurav Dhar, M.D.         
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Principal Investigator: Paul Sorajja, M.D.         
Mayo Clinic Completed
Rochester, Minnesota, United States, 55905
United States, Mississippi
North Mississippi Medical Center Recruiting
Tupelo, Mississippi, United States, 38801
Principal Investigator: David Talton, M.D.         
United States, Missouri
St. Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Principal Investigator: Keith Allen, M.D.         
Principal Investigator: Adnan Chhatriwalla, M.D.         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Principal Investigator: Robert Merritt, M.D.         
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Alan Zajarias, M.D.         
United States, New Hampshire
Catholic Medical Center Recruiting
Manchester, New Hampshire, United States, 03102
Principal Investigator: James Flynn, M.D.         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Principal Investigator: Carlos Ruiz, M.D.         
Principal Investigator: Elie Elmann, M.D.         
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Principal Investigator: Mark Russo, M.D.         
Principal Investigator: Marc Cohen, M.D.         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Principal Investigator: Francis Ferdinand, M.D.         
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Principal Investigator: Robert Frankel, M.D.         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Principal Investigator: Richard Schwartz, D.O.         
New York Presbyterian Hospital / Cornell University Recruiting
New York, New York, United States, 10021
Principal Investigator: Arash Salemi, M.D.         
Principal Investigator: Shing-Chiu Wong, M.D.         
Lenox Hill Hospital Active, not recruiting
New York, New York, United States, 10075
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Principal Investigator: George Petrossian, M.D.         
Principal Investigator: Newell Robinson, M.D.         
United States, North Carolina
Mission Health and Hospitals Recruiting
Asheville, North Carolina, United States, 28803
Principal Investigator: Mark Groh, M.D.         
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: John Vavalle, M.D.         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Todd Kiefer, M.D.         
Principal Investigator: Jeffrey Gaca, M.D.         
East Carolina Heart Institute Recruiting
Greenville, North Carolina, United States, 27834
Principal Investigator: Andy Kiser, M.D.         
United States, Ohio
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: E. Murat Tuzcu, M.D.         
Principal Investigator: Lars Svensson, M.D. Ph.D.         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Scott Lilly, M.D.         
United States, Oklahoma
Oklahoma Heart Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73120
Principal Investigator: Mohammad Ghani, M.D.         
Principal Investigator: Robert Bodenhamer, M.D.         
United States, Pennsylvania
Pinnacle Health System Recruiting
Harrisburg, Pennsylvania, United States, 17105
Principal Investigator: Hemal Gada, M.D.         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Jay Giri, M.D.         
Principal Investigator: Nimesh Desai, M.D. Ph.D.         
Allegheny Singer Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Principal Investigator: Ramzi Khalil, M.D.         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Thomas Gleason, M.D.         
Principal Investigator: Joon Sup Lee, M.D.         
Main Line Health Center/Lankenau Hospital Recruiting
Wynnewood, Pennsylvania, United States, 19096
Principal Investigator: Roberto Rodriguez, M.D.         
United States, South Dakota
Sanford USD Medical Center Not yet recruiting
Sioux Falls, South Dakota, United States, 57117
Principal Investigator: Thomasz Stys, M.D.         
United States, Tennessee
Baptist Memorial Hospital Recruiting
Memphis, Tennessee, United States, 38120
Principal Investigator: Edward Garrett, M.D.         
Centennial Medical Center Recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: Seenu Reddy, M.D.         
Principal Investigator: John Riddick, M.D.         
United States, Texas
Heart Hospital of Austin Recruiting
Austin, Texas, United States, 78756
Principal Investigator: Faraz Karendi, M.D.         
Principal Investigator: Frank Zidar, M.D.         
CHI St. Luke's Health Baylor College of Medicine Medical Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Joseph Coselli, M.D.         
Principal Investigator: Guilherme Silva, M.D.         
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Igor Gregoric, M.D.         
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Neal Kleiman, M.D.         
Principal Investigator: Michael Reardon, M.D.         
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Principal Investigator: David Brown, M.D.         
Principal Investigator: William Brinkman, M.D.         
United States, Utah
University of Utah Hospital Recruiting
Salt Lake City, Utah, United States, 84132
Principal Investigator: Anwar Tandar, M.D.         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Principal Investigator: Niv Ad, M.D.         
Principal Investigator: Bryan Raybuck, M.D.         
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Principal Investigator: Paul Mahoney, M.D.         
Australia, New South Wales
Macquarie University Hospital Recruiting
Sydney, New South Wales, Australia, 2109
Principal Investigator: Martin Ng, M.D.         
Australia, Queensland
The Prince Charles Hospital Recruiting
Chermside, Queensland, Australia, 4032
Principal Investigator: Darren Walters, M.D.         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Principal Investigator: Stephen Worthley, MBBS PhD         
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Principal Investigator: Tony Walton, M.D.         
Australia, Western Australia
Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
Principal Investigator: Gerald Yong, M.D.         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Raj Makkar, MD Cedars-Sinai Medical Center
Principal Investigator: Gregory Fontana, MD Los Robles Regional Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02000115     History of Changes
Other Study ID Numbers: 1203
First Submitted: November 26, 2013
First Posted: December 3, 2013
Last Update Posted: March 20, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction