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NCT02000115 · ClinicalTrials.gov registry record · NA

Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

A NA study of Aortic Valve Stenosis, sponsored by Abbott Medical Devices.

Active
Registry status
NA
Development phase
1,242
Enrollment target
20
Study locations

NCT02000115: Active NA study of Aortic Valve Stenosis, sponsored by Abbott Medical Devices.

NCT02000115 is a NA study of Aortic Valve Stenosis that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 1,242 participants, above the 1,002-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (24% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02000115, a NA study of Aortic Valve Stenosis, is active but no longer recruiting, sponsored by Abbott Medical Devices.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
1,242 participants
Enrollment target
20
Study locations

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.

Primary Outcome

A composite of all-cause mortality or disabling stroke at one year.

Conditions Studied

Aortic Valve Stenosis

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

FieldValue
Enrollment Target 1,242 participants
Start Date 2014-05
Est. Completion 2026-12
Phase NA
Abbott Medical Devices

261 total trials

What the registry record for NCT02000115 still lists

NCT02000115 is an interventional study that assigns participants to a tested intervention. Its 1,242 participants enrollment target places it among the larger protocols in the corpus, above the 1,002-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (24% higher).

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.

NCT02000115 names 20 study sites across 8 states, led by California, Florida, Alabama.

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.

What interventions are being tested in trial NCT02000115?

The interventions under investigation include: Portico transcatheter aortic valve (DEVICE), Commercially available transcatheter aortic valve (DEVICE).

Who is sponsoring clinical trial NCT02000115?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Aortic Valve Stenosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02000115's enrollment target sits among peer trials

1,242 5th of 30 higher than 26 of 30 other Aortic Valve Stenosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Aortic Valve Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02000115, the US trial registry maintained by the National Library of Medicine. NCT02000115 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.