New heart valve procedure shows promise for severe aortic stenosis

NCT ID NCT04788888

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new heart valve called the NAVITOR, placed using a thin tube (catheter) without open-heart surgery. It includes 434 people with severe aortic stenosis who are at intermediate or low risk for surgery. The main goals are to check for leaks around the valve at 30 days and to measure survival and stroke rates at 12 months.

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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

434 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Feb 2036

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.

Inclusion Criteria: 1. Subject who is judged by a Heart Team, including a cardiac surgeon, to be appropriate for transcatheter heart valve intervention therapy, and is deemed to be at intermediate or low risk for open surgical aortic valve replacement (i.e., heart team estimates risk of surgical mortality \< 7% at 30 days, considering the Society of Thoracic Surgeons (STS) risk score, overall clinical status, and other clinical co-morbidities unmeasured by the risk calculator). \* 2. New York Heart Association (NYHA) Functional Classification of II, III, or IV \* 3. Degenerative aortic valve stenosis with echo-derived criteria, defined as: aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed EOA ≤ 0.6 cm2/m2) AND either mean gradient ≥ 40 mmHg or peak jet velocity ≥ 4.0 m/s or doppler velocity index (DVI) ≤ 0.25. The echocardiogram supporting the qualifying AVA baseline measurement must be performed within 90 days prior to informed consent). \* 4. Aortic annulus diameter of 19-30 mm and ascending aorta diameter of 26-44 mm for the specified valve size listed in the IFU, as measured by CT (systolic phase) conducted within 12 months prior to informed consent. Exclusion Criteria: 1. Life expectancy is less than 2 years in the opinion of the Investigator. 2. Evidence of an acute myocardial infarction \[defined as ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with acute ischemia symptoms and troponin elevation\] within 30 days prior to index procedure. 3. Untreated clinically significant coronary artery disease requiring revascularization. 4. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior (except pacemaker or implantable cardioverter defibrillator (ICD) implant) to index procedure or planned within 30 days following the index procedure. 5. 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 6. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation 7. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA) 8. Renal insufficiency (creatinine \> 3.0 mg/dL or eGFR \< 30 ml/min/1.73m2) and/ or end stage renal disease requiring chronic dialysis 9. Hostile chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk (i.e., mediastinitis, radiation damage, abnormal chest wall, porcelain aorta, adhesion of aorta or internal mammary artery to sternum, etc.) \* 10. Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk \* 11. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+) \* 12. Aortic valve is a congenital unicuspid or congenital bicuspid valve as verified by echocardiography or CT \* 13. Severe ventricular dysfunction with LVEF \< 30% as measured by resting echocardiogram 14. Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position \* (Note: Subjects with a bioprosthetic aortic valve may be included in the ViV cohort.) 15. Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT) \* 16. Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis with pulmonary compromise 17. Minimum access vessel diameter of \< 5.0 mm for small FlexNav Delivery System and \< 5.5 mm for large FlexNav Delivery System 18. Eccentricity ratio of the annulus \< 0.73 * Criterion not applicable for valve-in-valve application

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

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

AKH Wien

Vienna, Austria
Azienda Ospedale Università Padova

Padova, Padua, 35128, Italy
CHU Gabriel Montpied

Clermont-Ferrand, France
Centro Cardiologico Monzino

Milan, Italy
Clinique Pasteur Toulouse

Toulouse, France
DHZ München

München, Germany
Erasmus MC - Thoraxcenter

Rotterdam, Rotterdam, 3015, Netherlands
Fiona Stanley Hospital

Murdoch, Murdoch, WA 6150, Australia
HerzZentrum Hirslanden

Zurich, Switzerland
Herzzentrum Dresden

Dresden, Germany
Herzzentrum Leipzig GmbH

Leipzig, Germany
Hopital Haut Leveque

Pessac, France
Hospital Clinico Universitario San Carlos

Madrid, Madrid, 28040, Spain
Hospital Clínic de Barcelona

Barcelona, Spain
Hospital General Universitario Dr. Balmis

Alicante, Spain
Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain
Hospital Virgen de Rocio

Seville, Spain
Kepler Universitätsklinikum GmbH

Linz, Austria
Kerckhoff-Klinik GgmbH

Bad Nauheim, Germany
Kings College Hospital

London, United Kingdom
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt, Germany
Leeds General Infirmary

Leeds, United Kingdom
Macquirie University Hopsital

Ryde, Australia
Morriston Hospital

Swansea, Swansea, SA6 6NL, United Kingdom
Ospedale San Raffaele - Cardiac

Milan, Italy
Pineta Grande Hospital

Castel Volturno, Caserta, 81030, Italy
Policlinico San Donato

Milan, Milan, 20097, Italy
Prince of Wales Hospital

Sydney, Sydney, NSW 2031, Australia
Princess Alexandra Hospital

Woolloongabba, Woolloongabba, QLD 4102,, Australia
Rigshospitalet

Copenhagen, Denmark
Royal Victoria Hospital

Belfast, United Kingdom
Shaare Zedek Medical Center

Jerusalem, Telaviv, 9103012, Israel
St. Andrew's Hospital

Adelaide, Australia
St. Johannes-Hospital

Dortmund, Germany
The Alfred Hospital

Melbourne, Australia
UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, Germany
Universitätsmedizin Berlin - Charité Campus Mitte (CCM)

Berlin, Germany

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