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Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

NCT02000115 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1242

Last updated 2025-07-20

Study results available
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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

  • Aortic Valve Stenosis

Interventions

DEVICE

Portico transcatheter aortic valve

St. Jude Medical transcatheter Portico aortic valve

DEVICE

Commercially available transcatheter aortic valve

Commercially available transcatheter aortic valve

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Raj R Makkar, MD · Cedars-Sinai Medical Center

  • Gregory P Fontana, MD · Los Robles Regional Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2019-10-31
Completion
2026-12-31

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02000115 on ClinicalTrials.gov