Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:2/3/2019
Start Date:May 2014
End Date:June 2024
Contact:Scott Skorupa
Email:scott.skorupa@abbott.com
Phone:651-756-4235

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The PORTICO IDE 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.

The PORTICO IDE 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 FlexNav study will be conducted as a separate arm of the PORTICO IDE trial and will
include 100 high or extreme risk patients. Safety data for the FlexNav™ Delivery System will
be summarized and descriptively compared to the first-generation Portico Delivery System.

Following completion of enrollment in the randomized cohort, subjects will be eligible for
enrollment in the Portico IDE Continued Access Protocol (CAP) Study.

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

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).
We found this trial at
66
sites
Los Angeles, California 90033
Principal Investigator: Vaughn Starnes, M.D.
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Ignacio Inglessis, M.D.
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Boston, MA
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: John Vavalle, M.D.
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Niv Ad, M.D.
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Raj Makkar, M.D.
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Jay Giri, M.D.
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Albany, New York 12208
Principal Investigator: Lewis Britton, M.D.
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Asheville, North Carolina 28803
Principal Investigator: Mark Groh, M.D.
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Chandan Devireddy, M.D.
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlantis, Florida 33462
Principal Investigator: Mark Rothenberg, M.D.
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Austin, Texas 78756
Principal Investigator: Faraz Karendi, M.D.
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Birmingham, Alabama 35294
Principal Investigator: Mark Sasse, M.D.
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Principal Investigator: Robert Frankel, M.D.
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Clearwater, Florida 33756
Principal Investigator: Lang Lin, M.D.
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: E. Murat Tuzcu, M.D.
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Scott Lilly, M.D.
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Concord, California 94520
Principal Investigator: Gary Gershony, M.D.
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Delray Beach, Florida 33431
Principal Investigator: Brijeshwar Maini, M.D.
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Todd Kiefer, M.D.
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Greenville, North Carolina 27834
Principal Investigator: Andy Kiser, M.D.
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Carlos Ruiz, M.D.
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Harrisburg, Pennsylvania 17101
Principal Investigator: Hemal Gada, M.D.
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Principal Investigator: Mark Kozak, M.D.
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Houston, Texas 77030
Principal Investigator: Igor Gregoric, M.D.
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Houston, Texas 77030
Principal Investigator: Joseph Coselli, M.D.
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Houston, Texas 77030
Principal Investigator: Neal Kleiman, M.D.
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Indianapolis, Indiana
Principal Investigator: James Hermiller, M.D.
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Kansas City, Missouri 64111
Principal Investigator: Keith Allen, M.D.
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La Jolla, California 92037
Principal Investigator: Paul Teirstein, M.D.
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Lansing, Michigan 48912
Principal Investigator: Norbert Baumgartner, M.D.
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Manchester, New Hampshire 03102
Principal Investigator: James Flynn, M.D.
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Memphis, Tennessee 38120
Principal Investigator: Edward Garrett, M.D.
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259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: Richard Schwartz, D.O.
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Principal Investigator: Paul Sorajja, M.D.
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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Nashville, Tennessee 37203
Principal Investigator: Seenu Reddy, M.D.
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Principal Investigator: Stephen Ramee, M.D.
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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New York, New York 10021
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New York, New York 10065
Principal Investigator: Arash Salemi, M.D.
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Principal Investigator: Mark Russo, M.D.
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Newport Beach, California 92658
Principal Investigator: Anthony Caffarelli, M.D.
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Principal Investigator: Paul Mahoney, M.D.
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Principal Investigator: Ravi Ramana, M.D.
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Oklahoma City, Oklahoma 73120
Principal Investigator: Mohammad Ghani, M.D.
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Orlando, Florida 32803
Principal Investigator: Andrew Taussig, M.D.
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Palo Alto, California 94304
Principal Investigator: William Fearon, M.D.
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Pasadena, California 91105
Principal Investigator: Azhil Durairaj, M.D.
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Phoenix, Arizona 85006
Principal Investigator: Ashish Pershad, M.D.
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Thomas Gleason, M.D.
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Pittsburgh, Pennsylvania 15212
Principal Investigator: Ramzi Khalil, M.D.
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Plano, Texas 75093
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Rochester, Minnesota 55905
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Roslyn, New York 11576
Principal Investigator: George Petrossian, M.D.
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Sacramento, California 95815
Principal Investigator: David Roberts, M.D.
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Sacramento, California 95819
Principal Investigator: Joseph Kozina, M.D.
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Saint Louis, Missouri 63110
Principal Investigator: Alan Zajarias, M.D.
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Salt Lake City, Utah 84132
Principal Investigator: Anwar Tandar, M.D.
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Ming Zhang, M.D.
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Sioux Falls, South Dakota 57117
Principal Investigator: Thomasz Stys, M.D.
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1235 E Cherokee St
Springfield, Missouri 65804
(417) 820-2000
Principal Investigator: Robert Merritt, M.D.
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Sydney, New South Wales
Principal Investigator: Martin Ng, M.D.
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Thousand Oaks, California 91360
Principal Investigator: Gregory Fontana, M.D.
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Tupelo, Mississippi 38801
Principal Investigator: David Talton, M.D.
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Principal Investigator: Paul Corso, M.D.
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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West Des Moines, Iowa 50266
Principal Investigator: Atul Chawla, M.D.
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Wichita, Kansas 67226
Principal Investigator: Bassem Chehab, M.D.
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Wynnewood, Pennsylvania 19096
Principal Investigator: Roberto Rodriguez, M.D.
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