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NCT04011722 · ClinicalTrials.gov registry record · NA
Portico Next Generation Approval Study
A NA study of Symptomatic Severe Aortic Stenosis, sponsored by Abbott Medical Devices.
- Active
- Registry status
- NA
- Development phase
- 333
- Enrollment target
- 20
- Study locations
NCT04011722: Active NA study of Symptomatic Severe Aortic Stenosis, sponsored by Abbott Medical Devices.
NCT04011722 is a NA study of Symptomatic Severe Aortic Stenosis that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 333 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04011722, a NA study of Symptomatic Severe Aortic Stenosis, is active but no longer recruiting, sponsored by Abbott Medical Devices.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 333 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
All-cause mortality is defined as the total number of deaths in each cohort at 30 days.
Conditions Studied
Interventions
- DEVICE Portico™ NG (Navitor) Valve and FlexNav™ Delivery System
- DEVICE Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
Study Locations (20)
New York
- Albany Medical Center - Albany
- Columbia University Medical Center/NYPH - New York
- Montefiore Medical Center - Moses Division - New York
California
- Cedars-Sinai Medical Center - Los Angeles
- Los Robles Regional Medical Center - Thousand Oaks
Texas
- The Methodist Hospital - Houston
- The Heart Hospital Baylor Plano - Plano
District of Columbia
- Washington Hospital Center - Washington D.C.
Illinois
- Advocate Christ Medical Center - Oak Lawn
Indiana
- St. Vincent Hospital - Indianapolis
Kansas
- Via Christi Regional Medical Center - Wichita
Michigan
- Sparrow Clinical Research Institute - Lansing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2019-09-17 |
| Est. Completion | 2027-12 |
| Phase | NA |
What the registry record for NCT04011722 still lists
NCT04011722 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Symptomatic Severe Aortic Stenosis appearing as the primary indexed condition, and to 2 interventions - of which Portico™ NG (Navitor) Valve and FlexNav™ Delivery System is the first listed.
NCT04011722 names 20 study sites across 16 states, led by New York, California, Texas.
Frequently Asked Questions
What is clinical trial NCT04011722 about?
NCT04011722 is a clinical study titled "Portico Next Generation Approval Study". 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 e...
What is the current status of trial NCT04011722?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 333 participants. The study started on 2019-09-17. Estimated completion is 2027-12.
What conditions does trial NCT04011722 study?
This clinical trial studies the following conditions: Symptomatic Severe Aortic Stenosis.
What interventions are being tested in trial NCT04011722?
The interventions under investigation include: Portico™ NG (Navitor) Valve and FlexNav™ Delivery System (DEVICE), Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System (DEVICE).
Who is sponsoring clinical trial NCT04011722?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04011722 being conducted?
This trial has 20 study locations across California, District of Columbia, Illinois, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04011722's enrollment target sits among peer trials
333 306th of 2000 higher than 1,695 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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