Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 20 study locations across 16 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04011722
The ClinicalTrials.gov registry entry for NCT04011722 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 333 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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
Similar trials for Symptomatic Severe Aortic Stenosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.