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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 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.

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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.

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

Sponsor

Abbott Medical Devices

261 total trials

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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, categorized as NA. The registered enrollment target is 1,242 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,002-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (24% higher). The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.