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ACTIVE NOT RECRUITING NA

Portico Next Generation Approval Study

NCT04011722 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 333 participants
Start Date 2019-09-17
Est. Completion 2027-12
Phase NA

Sponsor

Abbott Medical Devices

155 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04011722 reports 20 study locations spanning 16 distinct geographic areas — top geographies include New York, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04011722?

This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial