Portico Next Generation Approval Study (NCT04011722)
Evaluation of the Portico™ NG (Next Generation) Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cedars-Sinai Medical Center — Los Angeles, California
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (28 Sites)
Showing the first 25 of 28 sites.
- Cedars-Sinai Medical Center — Los Angeles, California
- Los Robles Regional Medical Center — Thousand Oaks, California
- Washington Hospital Center — Washington D.C., District of Columbia
- Advocate Christ Medical Center — Oak Lawn, Illinois
- St. Vincent Hospital — Indianapolis, Indiana
- Via Christi Regional Medical Center — Wichita, Kansas
- Sparrow Clinical Research Institute — Lansing, Michigan
- Minneapolis Heart Institute — Minneapolis, Minnesota
- Atlantic Health System - Morristown Memorial Hospital — Morristown, New Jersey
- Albany Medical Center — Albany, New York
- Columbia University Medical Center/NYPH — New York, New York
- Montefiore Medical Center - Moses Division — New York, New York
- Mission Health & Hospitals — Asheville, North Carolina
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Providence St. Vincent Medical Center — Portland, Oregon
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- Baptist Memorial Hospital — Memphis, Tennessee
- The Methodist Hospital — Houston, Texas
- The Heart Hospital Baylor Plano — Plano, Texas
- Intermountain St. George Regional Hospital — St. George, Utah
- Sentara Norfolk General Hospital — Norfolk, Virginia
- St. Andrew's Hospital — Adelaide, South Australia
- The Alfred Hospital — Melbourne, Victoria
- Fiona Stanley Hospital — Murdoch, Western Australia
- Rigshospitalet — Copenhagen,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.