Aortic Valve StenosisPORTICO-IDENCT02000115

Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

A study testing Portico transcatheter aortic valve and Commercially available transcatheter aortic valve in people with Aortic Valve Stenosis, run by Abbott Medical Devices at 70 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Aortic Valve Stenosis
What is being tested?: Portico transcatheter aortic valve and Commercially available transcatheter aortic valve
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,242 participants
Where: 70 sitesin 2 countries
Study dates: May 2014to Dec 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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).

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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.
A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be adequately premedicated.
Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis.
Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions.
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).
Native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging.
Aortic root angulation > 70° (applicable for transfemoral patients only).
Currently participating in an investigational drug or device study.
Active bacterial endocarditis within 6 months prior to the index procedure.
Bulky calcified aortic valve leaflets in close proximity to coronary ostia.
Non-calcified aortic annulus
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).
Additional Exclusion Criteria (Transcatheter Access Related)
For selection of an appropriate alternative access delivery method, subjects were screened using the following access specific exclusion criteria:
Transaortic (TAo) Subject Cohort Specific Exclusion Criteria
Subject has pre-existing patent RIMA graft that would preclude access.
Subject has a hostile chest or other condition that complicates transaortic access.
Subject has a porcelain aorta, defined as an extensive circumferential calcification of the ascending aorta that would complicate TAo access.
Additional exclusion criteria for transaortic access using the FlexNav™ Delivery System:
Subject has a distance between the annular plane and the aortic access site <7 cm (2.8")
Subject has a distance between the annular plane and the separate introducer sheath distal tip <6 cm (2.4")
Subclavian/Axillary Subject Cohort Specific Exclusion Criteria
Subject's access vessel (subclavian/axillary) diameter will not allow for introduction of the applicable 18 Fr or 19 Fr delivery system.
Subject's subclavian/axillary arteries have severe calcification and/or tortuosity.
Subject's aortic root angulation is:
Left Subclavian/Left Axillary: >70◦
Right Subclavian/Right Axillary: >30◦
Subject has a history of patent LIMA/RIMA graft that would preclude access
Additional exclusion criteria for subclavian/axillary access using the FlexNav™ Delivery System:
Subject's access vessel (subclavian/axillary) has a distance between the annular plane and the integrated sheath distal tip <17 cm (6.7")
Subject's access vessel requires the delivery system to be advanced through a separate introducer sheath

Trial locations and contacts

70 sites in 2 countries.

Country

City, postcode or hospital

70 sites in 2 countries

United States65 sites

Albany Medical Center
Albany, New York, 12208
Mission Health and Hospitals
Asheville, North Carolina, 28803
Emory University Hospital
Atlanta, Georgia, 30308
JFK Medical Center
Atlantis, Florida, 33462
Heart Hospital of Austin
Austin, Texas, 78756
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35249
Massachusetts General Hospital
Boston, Massachusetts, 02114
Maimonides Medical Center
Brooklyn, New York, 11219
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Morton Plant Valve Clinic
Clearwater, Florida, 33756
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
John Muir Medical Center
Concord, California, 94520
Delray Medical Center
Delray Beach, Florida, 33484
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
East Carolina Heart Institute
Greenville, North Carolina, 27834
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Pinnacle Health System
Harrisburg, Pennsylvania, 17105
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas, 77030
Memorial Hermann Hospital
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
St. Vincent Hospital
Indianapolis, Indiana, 46290
St. Luke's Hospital
Kansas City, Missouri, 64111
Scripps Green Hospital
La Jolla, California, 92037
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
USC University Hospital
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Catholic Medical Center
Manchester, New Hampshire, 03102
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Winthrop University Hospital
Mineola, New York, 11501
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Centennial Medical Center
Nashville, Tennessee, 37203
Ochsner Medical Center
New Orleans, Louisiana, 70121
New York Presbyterian Hospital / Cornell University
New York, New York, 10021
Lenox Hill Hospital
New York, New York, 10075
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Advocate Christ Medical Center
Oak Lawn, Illinois, 60653
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Florida Hospital Orlando
Orlando, Florida, 32803
Stanford University Medical Center
Palo Alto, California, 94305
Huntington Memorial Hospital
Pasadena, California, 91109
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Mayo Clinic
Rochester, Minnesota, 55905
St. Francis Hospital
Roslyn, New York, 11576
Sutter Memorial Hospital
Sacramento, California, 95816
Mercy General Hospital
Sacramento, California, 95819
University of Utah Hospital
Salt Lake City, Utah, 84132
Swedish Medical Center
Seattle, Washington, 98107
Sanford USD Medical Center
Sioux Falls, South Dakota, 57117
Mercy Hospital Springfield
Springfield, Missouri, 65804
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Iowa Heart Center
West Des Moines, Iowa, 50266
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
Main Line Health Center/Lankenau Hospital
Wynnewood, Pennsylvania, 19096

Other trials in United States

Australia5 sites

Royal Adelaide Hospital
Adelaide, South Australia, 5000
The Prince Charles Hospital
Chermside, Queensland, 4032
The Alfred Hospital
Melbourne, Victoria, 3004
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Macquarie University Hospital
Sydney, New South Wales, 2109

Other trials in Australia

About this study

Read the 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
Being tested: Portico transcatheter aortic valve, Commercially available transcatheter aortic valve
Keywords: Portico
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Portico transcatheter aortic valveDevice
St. Jude Medical transcatheter Portico aortic valve
Commercially available transcatheter aortic valveDevice
Commercially available transcatheter aortic valve

Study groups in NCT02000115
Study group	Role	What they receive
Randomized IDE Cohort, Portico Valve	Experimental	Portico transcatheter aortic valve and Portico delivery system. Status: ACTIVE, NOT ENROLLING. Receives: Device: Portico transcatheter aortic valve
Randomized IDE Cohort, CAV	Active comparator	Any FDA approved, commercially-available transcatheter aortic valve (CAV). Status: ACTIVE, NOT ENROLLING. Receives: 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. Receives: Device: Portico transcatheter aortic valve
FlexNav Delivery System Study	Experimental	Portico transcatheter aortic valve and FlexNav delivery system Status: ACTIVE, NOT ENROLLING Receives: Device: Portico transcatheter aortic valve

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Effectiveness Endpoint (Randomized IDE Cohort)
A composite of all-cause mortality or disabling stroke at one year.
Measured: 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.
Measured: 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
Measured: 30 days from index procedure

Secondary outcomes (6)

Percentage of Patients With Severe Aortic Regurgitation (Randomized IDE Cohort)
Severe aortic regurgitation (AR) at one year
Measured: One year
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (Randomized IDE Cohort)
Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year. Scale 0 to 100; with higher scores indicating better symptoms and physical functioning
Measured: One year
Percentage of Patients With Moderate or Severe Aortic Regurgitation (Randomized IDE Cohort)
Moderate or severe aortic regurgitation at one year
Measured: One year
Six-Minute Walk Test- Total Distance Walked (Randomized IDE Cohort)
Six-minute walk distance at one year
Measured: One year
Percentage of Patients With Composite Safety Endpoint (Nested Valve-in-Valve Registry)
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 from index procedure.
Anticipated completion date (2022)
Measured: 30 days from index procedure
Percentage of Patients With All-cause Mortality or Disabling Stroke (Nested Valve-in-Valve Registry)
A composite of all-cause mortality or disabling stroke at one year Anticipated completion data (2023)
Measured: One year from index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Dec 2026

First posted3 Dec 2013 (estimated)
Study startMay 2014
Primary completionOct 2019
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,242 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02000115
Sponsor's protocol ID: 1203
Acronym: PORTICO-IDE
Status last verified: Jul 2025
First submitted: 26 Nov 2013
Last updated: 20 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 41133305
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.
PubMed 32593323
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.
PubMed 26436963

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
ClinicalTrials.gov ID: NCT02000115
Acronym / sponsor ID: PORTICO-IDE / 1203
Conditions: Aortic Valve Stenosis
Keywords: Portico
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 1,242 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: May 2014 (actual)
Primary completion: Oct 2019 (actual)
Study completion: Dec 2026 (estimated)
First posted: 3 Dec 2013 (estimated)
Results: Posted 12 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Randomized IDE Cohort, Portico Valve	Experimental	Device: Portico transcatheter aortic valvePortico transcatheter aortic valve and Portico delivery system. Status: ACTIVE, NOT ENROLLING.
Randomized IDE Cohort, CAV	Active comparator	Device: Commercially available transcatheter aortic valveAny FDA approved, commercially-available transcatheter aortic valve (CAV). Status: ACTIVE, NOT ENROLLING.
Nested Valve-in-Valve Registry	Experimental	Device: Portico transcatheter aortic valveSubjects who have documented failed aortic surgical valve prosthesis and are deemed eligible to receive a transcatheter Portico valve Status: ACTIVE, ENROLLING.
FlexNav Delivery System Study	Experimental	Device: Portico transcatheter aortic valvePortico transcatheter aortic valve and FlexNav delivery system Status: ACTIVE, NOT ENROLLING

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (46 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Portico transcatheter aortic valveSt. Jude Medical transcatheter Portico aortic valve	Device	FlexNav Delivery System Study, Nested Valve-in-Valve Registry, Randomized IDE Cohort, Portico Valve
Commercially available transcatheter aortic valveCommercially available transcatheter aortic valve	Device	Randomized IDE Cohort, CAV

Primary outcome

Primary Effectiveness Endpoint (Randomized IDE Cohort)
Time frame: One-year from randomization
A composite of all-cause mortality or disabling stroke at one year.
Primary Safety Endpoint (Randomized IDE Cohort)
Time frame: 30 days from randomization
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.
Percentage of Patients With Major Vascular Complications (Primary Safety Endpoint- FlexNav Delivery System Study)
Time frame: 30 days from index procedure
Valve Academic Research Consortium (VARC) 2- defined major vascular complications

6 secondary outcomes

Percentage of Patients With Severe Aortic Regurgitation (Randomized IDE Cohort)
Time frame: One year
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (Randomized IDE Cohort)
Time frame: One year
Percentage of Patients With Moderate or Severe Aortic Regurgitation (Randomized IDE Cohort)
Time frame: One year
Six-Minute Walk Test- Total Distance Walked (Randomized IDE Cohort)
Time frame: One year
Percentage of Patients With Composite Safety Endpoint (Nested Valve-in-Valve Registry)
Time frame: 30 days from index procedure
Percentage of Patients With All-cause Mortality or Disabling Stroke (Nested Valve-in-Valve Registry)
Time frame: One year from index procedure

Results and safety

Results posted to the registry on 12 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Randomized IDE Cohort, Portico Valve	381	302
Randomized IDE Cohort, CAV	369	301
FlexNav Delivery System Study	100	99
Nested Valve-in-Valve Registry	53	0

Primary outcome: Primary Effectiveness Endpoint (Randomized IDE Cohort)

Time frame: One-year from randomization. Mean (Standard Error). Unit: percentage of participants

Measure	Randomized IDE Cohort, Portico Valve n = 381	Randomized IDE Cohort, CAV n = 369
Value	14.8 (1.8)	13.4 (1.8)

Randomized IDE Cohort, Portico Valve vs Randomized IDE Cohort, CAV: Difference in percentages between groups: 1.5, p = 0.006, Kaplan-Meier estimates

Population analysed: Intention-to-treat analysis population.

Primary outcome: Primary Safety Endpoint (Randomized IDE Cohort)

Time frame: 30 days from randomization. Mean (Standard Deviation). Unit: percentage of participants

Measure	Randomized IDE Cohort, Portico Valve n = 381	Randomized IDE Cohort, CAV n = 369
Value	13.8 (1.8)	9.6 (1.5)

Randomized IDE Cohort, Portico Valve vs Randomized IDE Cohort, CAV: Difference in percentages between groups: 4.2, p = 0.03, Kaplan-Meier estimates

Population analysed: Intention-to-treat analysis population

Primary outcome: Percentage of Patients With Major Vascular Complications (Primary Safety Endpoint- FlexNav Delivery System Study)

Time frame: 30 days from index procedure. Number. Unit: percentage of participants

Measure	FlexNav Delivery System Study n = 100
Value	6.0

Population analysed: All enrolled analysis subjects

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Randomized IDE cohort: data reflects all serious and other (non serious) adverse events through 1 year in the intention-to-treat population (i.e. within 365 days of randomization); and all-cause mortality reflects all deaths through 1 year. FlexNav Delivery System study: data reflects all serious and other (non serious) adverse events through 30 days in the enrolled analysis population (i.e. within 30 days from index procedure); and all-cause mortality reflects all deaths through 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Randomized IDE Cohort, Portico Valve	273 of 381 (71.7%)	298 of 381 (78.2%)	56 of 381
Randomized IDE Cohort, CAV	231 of 369 (62.6%)	269 of 369 (72.9%)	45 of 369
FlexNav Delivery System Study	44 of 100 (44%)	54 of 100 (54%)	0 of 100

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Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41133305Puri 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.
Derived from this study: PubMed 32593323Makkar 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.
Derived from this study: PubMed 26436963Makkar 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raj R Makkar, MD principal investigator

Cedars-Sinai Medical Center

Gregory P Fontana, MD principal investigator

Los Robles Regional Medical Center

70 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Endpoint (Randomized IDE Cohort) (time frame: One-year from randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02000115, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.