Portico Next Generation Approval Study
Public ClinicalTrials.gov record NCT04011722. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of the Portico™ NG (Next Generation) Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04011722
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 333 participants
Conditions and interventions
Conditions
Interventions
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System Device
- Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System Device
Device
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 17, 2019 (Actual)
- Primary completion
- Jan 12, 2023 (Actual)
- Completion
- Jan 2033 (Estimated)
- Last update posted
- Jul 21, 2026
2019 – 2033
United States locations
- U.S. sites
- 21
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Los Robles Regional Medical Center | Thousand Oaks | California | 91360 | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| St. Vincent Hospital | Indianapolis | Indiana | 46240 | — |
| Via Christi Regional Medical Center | Wichita | Kansas | 67214 | — |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | — |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | — |
| Atlantic Health System - Morristown Memorial Hospital | Morristown | New Jersey | 07962 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Columbia University Medical Center/NYPH | New York | New York | 10032 | — |
| Montefiore Medical Center - Moses Division | New York | New York | 10467 | — |
| Mission Health & Hospitals | Asheville | North Carolina | 28801 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | — |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | — |
| The Methodist Hospital | Houston | Texas | 77030 | — |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | — |
| Intermountain St. George Regional Hospital | St. George | Utah | 84790 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04011722, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 21, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04011722 live on ClinicalTrials.gov.