Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

NCT02000115 | Active Not Recruiting Results DMC

• 1 other identifier: 1203
• Study Type: interventional
• Target: 1,242
• Locations: 2 countries
• Sites: 70

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.

Conditions

Aortic Valve Stenosis

Keywords

Portico

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (6)

• Percentage of Patients With Severe Aortic Regurgitation (Randomized IDE Cohort)

  One year

• Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (Randomized IDE Cohort)

  One year

• Percentage of Patients With Moderate or Severe Aortic Regurgitation (Randomized IDE Cohort)

  One year

• Six-Minute Walk Test- Total Distance Walked (Randomized IDE Cohort)

  One year

• Percentage of Patients With Composite Safety Endpoint (Nested Valve-in-Valve Registry)

  30 days from index procedure

Study Arms (4)

Randomized IDE Cohort, Portico Valve

EXPERIMENTAL

Portico transcatheter aortic valve and Portico delivery system. Status: ACTIVE, NOT ENROLLING.

Device: Portico transcatheter aortic valve

Randomized IDE Cohort, CAV

ACTIVE COMPARATOR

Any FDA approved, commercially-available transcatheter aortic valve (CAV). Status: ACTIVE, NOT ENROLLING.

Device: Commercially available transcatheter aortic valve

Nested Valve-in-Valve Registry

EXPERIMENTAL

Subjects who have documented failed aortic surgical valve prosthesis and are deemed eligible to receive a transcatheter Portico valve Status: ACTIVE, ENROLLING.

Device: Portico transcatheter aortic valve

FlexNav Delivery System Study

EXPERIMENTAL

Portico transcatheter aortic valve and FlexNav delivery system Status: ACTIVE, NOT ENROLLING

Device: Portico transcatheter aortic valve

Interventions

Portico transcatheter aortic valve DEVICE

St. Jude Medical transcatheter Portico aortic valve

FlexNav Delivery System Study; Nested Valve-in-Valve Registry; Randomized IDE Cohort, Portico Valve

Commercially available transcatheter aortic valve DEVICE

Commercially available transcatheter aortic valve

Randomized IDE Cohort, CAV

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Society of Thoracic Surgeons (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.
• Subject is 21 years of age or older at the time of consent.
• 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 effective orifice area (EOA) ≤ 0.6 cm2/m2). (Qualifying AVA baseline measurement must be within 60 days prior to informed consent).
• Subject has symptomatic aortic stenosis as demonstrated by New York Heart Association (NYHA) Functional Classification of II, III, or IV.
• 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.
• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
• Subject's aortic annulus is 19-27mm diameter as measured by computerized tomography (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.
• For a subject to be considered an Extreme Risk candidate they must meet # 2, 3, 4, 5, 6, 7 of the above criteria, and
• 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.

You may not qualify if:

• Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.
• Aortic valve is a congenital unicuspid or congenital bicuspid valve or is non-calcified as verified by echocardiography.
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).
• Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.
• 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 left ventricular outflow tract (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.
• Blood dyscrasias as defined: leukopenia (WBC\<3000 mm3), acute anemia (Hb \< 9 g/dL), thrombocytopenia (platelet count \<50,000 cells/mm³).
• History of bleeding diathesis or coagulopathy.
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
• Untreated clinically significant coronary artery disease requiring revascularization.
• Hemodynamic instability requiring inotropic support or mechanical heart assistance.
• Need for emergency surgery for any reason.
• Hypertrophic cardiomyopathy with or without obstruction (HOCM).
• Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20% as measured by resting echocardiogram.
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months prior to index procedure.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (70)

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35249, United States

Location

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

John Muir Medical Center

Concord, California, 94520, United States

Location

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

USC University Hospital

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91109, United States

Location

Sutter Memorial Hospital

Sacramento, California, 95816, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Los Robles Regional Medical Center

Thousand Oaks, California, 91360, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

Morton Plant Valve Clinic

Clearwater, Florida, 33756, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Florida Hospital Orlando

Orlando, Florida, 32803, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60653, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46290, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

New York Presbyterian Hospital / Cornell University

New York, New York, 10021, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Mission Health and Hospitals

Asheville, North Carolina, 28803, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

East Carolina Heart Institute

Greenville, North Carolina, 27834, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Pinnacle Health System

Harrisburg, Pennsylvania, 17105, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Main Line Health Center/Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Sanford USD Medical Center

Sioux Falls, South Dakota, 57117, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Heart Hospital of Austin

Austin, Texas, 78756, United States

Location

CHI St. Luke's Health Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Swedish Medical Center

Seattle, Washington, 98107, United States

Location

Macquarie University Hospital

Sydney, New South Wales, 2109, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Related Publications (3)

• Puri R, Thiele H, Fichtlscherer S, Westermann D, Makkar R, Waksman R, Hakmi S, Sondergaard L, Groh M, Montarello JK, Kempfert J, Yong G, Bedogni F, Maisano F, Worthley SG, Rodes-Cabau J, Fontana GP, Mollmann H. Five-Year Clinical Outcomes and Durability of a Self-Expanding Transcatheter Heart Valve With Intra-Annular Leaflets. Circ Cardiovasc Interv. 2025 Dec;18(12):e015430. doi: 10.1161/CIRCINTERVENTIONS.125.015430. Epub 2025 Oct 24.

  PMID: 41133305 DERIVED

• Makkar RR, Cheng W, Waksman R, Satler LF, Chakravarty T, Groh M, Abernethy W, Russo MJ, Heimansohn D, Hermiller J, Worthley S, Chehab B, Cunningham M, Matthews R, Ramana RK, Yong G, Ruiz CE, Chen C, Asch FM, Nakamura M, Jilaihawi H, Sharma R, Yoon SH, Pichard AD, Kapadia S, Reardon MJ, Bhatt DL, Fontana GP. Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non-inferiority trial. Lancet. 2020 Sep 5;396(10252):669-683. doi: 10.1016/S0140-6736(20)31358-1. Epub 2020 Jun 25.

  PMID: 32593323 DERIVED

• Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.

  PMID: 26436963 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Daniella Corporan
• Organization: Abbott Structural Heart

daniella.corporan@abbott.com

779-220-7309

Study Officials

• Raj R Makkar, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Gregory P Fontana, MD

  Los Robles Regional Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: May 1, 2014
• Primary Completion: October 1, 2019
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 20, 2025
• Results First Posted: January 12, 2021

Record last verified: 2025-07

Locations

AU (5); US (65)