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Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
NCT02000115 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE Portico transcatheter aortic valve
- DEVICE Commercially available transcatheter aortic valve
Study Locations (20)
California
- John Muir Medical Center — Concord
- Scripps Green Hospital — La Jolla
- USC University Hospital — Los Angeles
- Cedars-Sinai Medical Center — Los Angeles
- Hoag Memorial Hospital Presbyterian — Newport Beach
- Stanford University Medical Center — Palo Alto
- Huntington Memorial Hospital — Pasadena
- Sutter Memorial Hospital — Sacramento
- Mercy General Hospital — Sacramento
- Los Robles Regional Medical Center — Thousand Oaks
Florida
- JFK Medical Center — Atlantis
- Morton Plant Valve Clinic — Clearwater
- Delray Medical Center — Delray Beach
- Florida Hospital Orlando — Orlando
Alabama
- University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham
Arizona
- Banner - University Medical Center Phoenix — Phoenix
District of Columbia
- Washington Hospital Center — Washington D.C.
Georgia
- Emory University Hospital — Atlanta
Illinois
- Advocate Christ Medical Center — Oak Lawn
Indiana
- St. Vincent Hospital — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,242 participants |
| Start Date | 2014-05 |
| Est. Completion | 2026-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02000115
The ClinicalTrials.gov registry entry for NCT02000115 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,242 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 2 interventions — of which Portico transcatheter aortic valve is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02000115 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02000115 about?
NCT02000115 is a clinical study titled "Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial". 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 ri...
What is the current status of trial NCT02000115?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,242 participants. The study started on 2014-05. Estimated completion is 2026-12.
What conditions does trial NCT02000115 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02000115?
The interventions under investigation include: Portico transcatheter aortic valve (DEVICE), Commercially available transcatheter aortic valve (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02000115?
This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02000115 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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