Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

NCT ID: NCT02000115

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2026-12-31

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.

Detailed Description

The PORTICO pivotal IDE trial will include a randomized cohort of 750 subjects enrolled at up to 70 investigational sites in the United States and Australia. Patients will be randomized (1:1) to receive the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) or any FDA-approved, commercially-available Transcatheter Aortic Valve Replacement (TAVR) System. The randomized cohort will be tested for two co-primary endpoints at 30 days (primary safety endpoint) and 1 year (primary effectiveness endpoint). At the time of the primary randomized cohort analysis, the risk cohorts will be combined and analysis will be conducted on the intention-to-treat (n=750) population.

The FlexNav Delivery System study will be conducted as a separate arm of the PORTICO IDE trial and will include up to 200 high or extreme risk subjects; including a minimum of 100 analysis subjects. The study will characterize the safety of the next-generation Portico Delivery System ("FlexNav™ Delivery System"). The primary analysis cohort will include FlexNav analysis subjects.

The IDE Valve-in-Valve registry will enroll up to 100 high or extreme risk subjects with a failed surgical bioprosthesis who are eligible to receive a Portico Transcatheter Heart Valve.

All subjects enrolled in the PORTICO pivotal IDE trial will undergo follow-up at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, 12-months and then annually through 5-years.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Randomized IDE Cohort, Portico Valve

Portico transcatheter aortic valve and Portico delivery system.

Status: ACTIVE, NOT ENROLLING.

Group Type: EXPERIMENTAL

Portico transcatheter aortic valve

Intervention Type: DEVICE

St. Jude Medical transcatheter Portico aortic valve

Randomized IDE Cohort, CAV

Any FDA approved, commercially-available transcatheter aortic valve (CAV).

Status: ACTIVE, NOT ENROLLING.

Group Type: ACTIVE_COMPARATOR

Commercially available transcatheter aortic valve

Intervention Type: DEVICE

Commercially available transcatheter aortic valve

Nested Valve-in-Valve Registry

Subjects who have documented failed aortic surgical valve prosthesis and are deemed eligible to receive a transcatheter Portico valve

Status: ACTIVE, ENROLLING.

Group Type: EXPERIMENTAL

Portico transcatheter aortic valve

Intervention Type: DEVICE

St. Jude Medical transcatheter Portico aortic valve

FlexNav Delivery System Study

Portico transcatheter aortic valve and FlexNav delivery system

Status: ACTIVE, NOT ENROLLING

Group Type: EXPERIMENTAL

Portico transcatheter aortic valve

Intervention Type: DEVICE

St. Jude Medical transcatheter Portico aortic valve

Interventions

Portico transcatheter aortic valve

St. Jude Medical transcatheter Portico aortic valve

Intervention Type: DEVICE

Commercially available transcatheter aortic valve

Commercially available transcatheter aortic valve

Intervention Type: DEVICE

Eligibility Criteria

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 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.

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 effective orifice area (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 New York Heart Association (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 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

8. 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.

Exclusion Criteria

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 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.

6. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 g/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 left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.

14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.

15. Active peptic ulcer or upper gastrointestinal (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).

1. Subject has pre-existing patent RIMA graft that would preclude access.

2. Subject has a hostile chest or other condition that complicates transaortic access.

3. Subject has a porcelain aorta, defined as an extensive circumferential calcification of the ascending aorta that would complicate TAo access.

1. Subject has a distance between the annular plane and the aortic access site <7 cm (2.8")

2. Subject has a distance between the annular plane and the separate introducer sheath distal tip <6 cm (2.4")

1. Subject's access vessel (subclavian/axillary) diameter will not allow for introduction of the applicable 18 Fr or 19 Fr delivery system.

2. Subject's subclavian/axillary arteries have severe calcification and/or tortuosity.

3. Subject's aortic root angulation is:

• Left Subclavian/Left Axillary: >70◦
• Right Subclavian/Right Axillary: >30◦

4. Subject has a history of patent LIMA/RIMA graft that would preclude access

1. Subject's access vessel (subclavian/axillary) has a distance between the annular plane and the integrated sheath distal tip <17 cm (6.7")

2. Subject's access vessel requires the delivery system to be advanced through a separate introducer sheath

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raj R Makkar, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Gregory P Fontana, MD

Role: PRINCIPAL_INVESTIGATOR

Los Robles Regional Medical Center

Locations

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

Birmingham, Alabama, United States

Banner - University Medical Center Phoenix

Phoenix, Arizona, United States

John Muir Medical Center

Concord, California, United States

Scripps Green Hospital

La Jolla, California, United States

USC University Hospital

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Huntington Memorial Hospital

Pasadena, California, United States

Sutter Memorial Hospital

Sacramento, California, United States

Mercy General Hospital

Sacramento, California, United States

Los Robles Regional Medical Center

Thousand Oaks, California, United States

Washington Hospital Center

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

JFK Medical Center

Atlantis, Florida, United States

Morton Plant Valve Clinic

Clearwater, Florida, United States

Delray Medical Center

Delray Beach, Florida, United States

Florida Hospital Orlando

Orlando, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

St. Vincent Hospital

Indianapolis, Indiana, United States

Iowa Heart Center

West Des Moines, Iowa, United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

St. Luke's Hospital

Kansas City, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Catholic Medical Center

Manchester, New Hampshire, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Albany Medical Center

Albany, New York, United States

Maimonides Medical Center

Brooklyn, New York, United States

Winthrop University Hospital

Mineola, New York, United States

New York Presbyterian Hospital / Cornell University

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Mission Health and Hospitals

Asheville, North Carolina, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

East Carolina Heart Institute

Greenville, North Carolina, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Pinnacle Health System

Harrisburg, Pennsylvania, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Main Line Health Center/Lankenau Hospital

Wynnewood, Pennsylvania, United States

Sanford USD Medical Center

Sioux Falls, South Dakota, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

Centennial Medical Center

Nashville, Tennessee, United States

Heart Hospital of Austin

Austin, Texas, United States

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

Houston, Texas, United States

Memorial Hermann Hospital

Houston, Texas, United States

The Methodist Hospital

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

University of Utah Hospital

Salt Lake City, Utah, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

Macquarie University Hospital

Sydney, New South Wales, Australia

The Prince Charles Hospital

Chermside, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Countries

United States; Australia

References

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 Oct 24:e015430. doi: 10.1161/CIRCINTERVENTIONS.125.015430. Online ahead of print.

Reference Type: DERIVED

PMID: 41133305 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32593323 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26436963 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1203

Identifier Type: -

Identifier Source: org_study_id