Who is eligible for clinical trial NCT02000115?

Participants must meet protocol criteria for Aortic Valve Stenosis. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT02000115 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-07-09

Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial (NCT02000115)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Abbott Medical Devices

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (41 items).

Location: University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (70 Sites)

University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama
Banner - University Medical Center Phoenix — Phoenix, Arizona
John Muir Medical Center — Concord, California
Scripps Green Hospital — La Jolla, California
USC University Hospital — Los Angeles, California
Cedars-Sinai Medical Center — Los Angeles, California
Hoag Memorial Hospital Presbyterian — Newport Beach, California
Stanford University Medical Center — Palo Alto, California
Huntington Memorial Hospital — Pasadena, California
Sutter Memorial Hospital — Sacramento, California
Mercy General Hospital — Sacramento, California
Los Robles Regional Medical Center — Thousand Oaks, California
Washington Hospital Center — Washington D.C., District of Columbia
JFK Medical Center — Atlantis, Florida
Morton Plant Valve Clinic — Clearwater, Florida
Delray Medical Center — Delray Beach, Florida
Florida Hospital Orlando — Orlando, Florida
Emory University Hospital — Atlanta, Georgia
Advocate Christ Medical Center — Oak Lawn, Illinois
St. Vincent Hospital — Indianapolis, Indiana
Iowa Heart Center — West Des Moines, Iowa
Cardiovascular Research Institute of Kansas — Wichita, Kansas
Ochsner Medical Center — New Orleans, Louisiana
Massachusetts General Hospital — Boston, Massachusetts
Sparrow Clinical Research Institute — Lansing, Michigan

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗