Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

NCT04788888 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: ABT-CIP-10342
• Study Type: interventional
• Target: 434
• Locations: 10 countries
• Sites: 35

Brief Summary

Evaluation of TAVR using the NAVITOR valve in a Global Investigation.

Conditions

Symptomatic Severe Aortic Stenosis

Keywords

NAVITOR Heart disease; Transcatheter aortic valve implantation (TAVI); Aortic stenosis Cardiovascular disease

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint: Percentage of Participants With Moderate or Greater Paravalvular Leak (PVL)

  The primary effectiveness endpoint is moderate or greater paravalvular leak (PVL) at 30 days, as assessed by the echocardiographic core laboratory. The hypothesis test was performed based on the implanted population in whom a functional Navitor valve remained implanted at 30 days.

  at 30 Days

• Primary Safety Endpoint: The Rates of All-cause Mortality or Fatal Stroke/Stroke With Disability

  The composite of rate of all-cause mortality or fatal stroke/stroke with disability at 12 months post index Navitor implantation procedure as adjudicated by the CEC per Valve Academic Research Consortium (VARC-3) definitions calculated against the performance goal of 11.3%.

  at 12 months

Secondary Outcomes (3)

• Mean Change in Mean Transvalvular Gradient

  Baseline to 12 months

• Mean Change in Effective Orifice Area (EOA)

  Baseline to12 months

• Mean Change In KCCQ Quality Of Life Score

  Baseline to 12 months

Study Arms (1)

Primary Analysis Cohort

EXPERIMENTAL

Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+)

Device: Navitor Transcatheter Aortic valve and FlexNav Delivery system

Interventions

Navitor Transcatheter Aortic valve and FlexNav Delivery system DEVICE

Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk. Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve and FlexNav Delivery system.

Primary Analysis Cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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). \*
• New York Heart Association (NYHA) Functional Classification of II, III, or IV \*
• 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). \*
• 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.

You may not qualify if:

• Life expectancy is less than 2 years in the opinion of the Investigator.
• 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.
• Untreated clinically significant coronary artery disease requiring revascularization.
• 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.
• 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
• Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
• Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
• Renal insufficiency (creatinine \> 3.0 mg/dL or eGFR \< 30 ml/min/1.73m2) and/ or end stage renal disease requiring chronic dialysis
• 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.) \*
• Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk \*
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+) \*
• Aortic valve is a congenital unicuspid or congenital bicuspid valve as verified by echocardiography or CT \*
• Severe ventricular dysfunction with LVEF \< 30% as measured by resting echocardiogram
• 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.)
• Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT) \*

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (37)

Fiona Stanley Hospital

Murdoch, Murdoch, WA 6150, Australia

Location

Prince of Wales Hospital

Sydney, Sydney, NSW 2031, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Woolloongabba, QLD 4102,, Australia

Location

St. Andrew's Hospital

Adelaide, Australia

Location

The Alfred Hospital

Melbourne, Australia

Location

Macquirie University Hopsital

Ryde, Australia

Location

Kepler Universitätsklinikum GmbH

Linz, Austria

Location

AKH Wien

Vienna, Austria

Location

Rigshospitalet

Copenhagen, Denmark

Location

CHU Gabriel Montpied

Clermont-Ferrand, France

Location

Hopital Haut Leveque

Pessac, France

Location

Clinique Pasteur Toulouse

Toulouse, France

Location

Kerckhoff-Klinik GgmbH

Bad Nauheim, Germany

Location

Universitätsmedizin Berlin - Charité Campus Mitte (CCM)

Berlin, Germany

Location

St. Johannes-Hospital

Dortmund, Germany

Location

Herzzentrum Dresden

Dresden, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt, Germany

Location

UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

DHZ München

München, Germany

Location

Shaare Zedek Medical Center

Jerusalem, Telaviv, 9103012, Israel

Location

Pineta Grande Hospital

Castel Volturno, Caserta, 81030, Italy

Location

Policlinico San Donato

Milan, Milan, 20097, Italy

Location

Azienda Ospedale Università Padova

Padova, Padua, 35128, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Ospedale San Raffaele - Cardiac

Milan, Italy

Location

Erasmus MC - Thoraxcenter

Rotterdam, Rotterdam, 3015, Netherlands

Location

Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Clinico Universitario San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital General Universitario Dr. Balmis

Alicante, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Virgen de Rocio

Seville, Spain

Location

HerzZentrum Hirslanden

Zurich, Switzerland

Location

Morriston Hospital

Swansea, Swansea, SA6 6NL, United Kingdom

Location

Royal Victoria Hospital

Belfast, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Results Point of Contact

• Title: Lihua Li, Principal Clinical Scientist
• Organization: Abbott

lihua.li1@abbott.com

+1 (612) 413-0527

Study Officials

• Stephen Worthley, M.D., Ph. D.

  Macquarie University Hospital

  PRINCIPAL INVESTIGATOR

• Nicolas van Mieghem, M.D., Ph. D.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Barathi Sethuraman

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 9, 2021
• Study Start: July 13, 2021
• Primary Completion: January 2, 2025
• Study Completion (Estimated): February 28, 2036
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8); DK (1); IT (5); NL (1); CH (1); IL (1); ES (5); AU (6); FR (3); GB (4)