Portico Next Generation Approval Study

Running, not enrolling · Not applicable

Conditions studied: Symptomatic Severe Aortic Stenosis

In brief

The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the rate of moderate or greater paravalvular leak at 30 days in a high or extreme surgical risk patient population to support CE (Conformité Européenne) Mark and FDA approval.

Key facts

Study ID

NCT04011722

Run by

Abbott Medical Devices

People needed

333

Starts

2019-09-17

Expected to finish

2033-01-01

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Los Robles Regional Medical Center — Thousand Oaks, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• St. Vincent Hospital — Indianapolis, Indiana, United States
• Via Christi Regional Medical Center — Wichita, Kansas, United States
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Atlantic Health System - Morristown Memorial Hospital — Morristown, New Jersey, United States
• Albany Medical Center — Albany, New York, United States
• Columbia University Medical Center/NYPH — New York, New York, United States
• Montefiore Medical Center - Moses Division — New York, New York, United States
• Mission Health & Hospitals — Asheville, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baptist Memorial Hospital — Memphis, Tennessee, United States
• The Methodist Hospital — Houston, Texas, United States
• The Heart Hospital Baylor Plano — Plano, Texas, United States
• Intermountain St. George Regional Hospital — St. George, Utah, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States
• St. Andrew's Hospital — Adelaide, South Australia, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia
• Rigshospitalet — Copenhagen, Denmark

Full record on ClinicalTrials.gov

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