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New heart valve offers hope for High-Risk patients

NCT ID NCT04011722

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study tests a next-generation heart valve (Navitor) in 333 people with severe aortic stenosis who are too high-risk for open-heart surgery. The goal is to see if the valve is safe and works well at 30 days, focusing on survival and reducing leaks around the valve. The valve is placed through a tube in the artery, avoiding major surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

333 people

The number who actually took part.

Started

Sep 2019

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score. 2. Subject has symptomatic aortic stenosis as demonstrated by NYHA (New York Heart Association) Functional Classification of II, III, or IV. 3. Subject has senile degenerative aortic valve stenosis with echo-derived criteria, defined as: aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed EOA (effective orifice area) ≤ 0.6 cm2/m2) AND mean gradient ≥40 mmHg or peak jet velocity ≥ 4.0 m/s or doppler velocity index (DVI) ≤0.25. (Qualifying AVA baseline measurement must be within 90 days prior to informed consent). 4. Aortic annulus diameter of 19-30mm and ascending aorta diameter for the specified valve size listed in the IFU (Instructions For Use), as measured by CT (Computed Tomography) Key Exclusion Criteria: 1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure. 2. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure. 3. Blood dyscrasias as defined: leukopenia (WBC\<3000 mm3), acute anemia (Hb \< 9 g/dL), thrombocytopenia (platelet count \<50,000 cells/mm³). History of bleeding diathesis or coagulopathy 4. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation 5. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA). 6. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+). 7. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT), severe (greater than or equal to 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise. 8. Minimum access vessel diameter of \<5.0mm for small FlexNav™ Delivery System and \<5.5 mm for large FlexNav™ Delivery System

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis heart valve disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Symptomatic severe aortic stenosis

Contacts and locations

Locations

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453, United States

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Atlantic Health System - Morristown Memorial Hospital

    Morristown, New Jersey, 07962, United States

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Columbia University Medical Center/NYPH

    New York, New York, 10032, United States

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Intermountain St. George Regional Hospital

    St. George, Utah, 84790, United States

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360, United States

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407, United States

  • Mission Health & Hospitals

    Asheville, North Carolina, 28801, United States

  • Montefiore Medical Center - Moses Division

    New York, New York, 10467, United States

  • Morriston Hospital - ABM University Health Board

    Morriston, SWANSEA, SA6 6NL, United Kingdom

  • Policlinico San Donato

    San Donato Milanese, Lombard, 20097, Italy

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225, United States

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Royal Victoria Hospital

    Belfast, Northern Ireland, BT12 6BA, United Kingdom

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912, United States

  • St. Andrew's Hospital

    Adelaide, South Australia, 5000, Australia

  • St. Vincent Hospital

    Indianapolis, Indiana, 46240, United States

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • The Methodist Hospital

    Houston, Texas, 77030, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214, United States

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

More trials for these conditions

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