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Navitor heart valve for people with severe aortic stenosis needing valve replacement

Tests the Navitor replacement heart valve in adults with severe aortic stenosis.

Key facts

Who runs it
Abbott Medical Devices
Where
Jerusalem and Petah Tikva, IsraelSee the 2 sitesAlso in 12 other countries, 105 sites
Trial code
Registry title
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
Status
Enrolling by invitation
People taking part
1,500 people, planned
Started
15 Mar 2024
Expected to end
Apr 2036
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Navitor Transcatheter Aortic Valve Implantation (TAVI) System
  • Any Commercially Available Transcatheter Aortic Valve (CAV) System
Record updated
11 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe aortic stenosis that causes symptoms. In the main group, people have low or intermediate risk from open heart surgery. Other groups include people whose earlier replacement valve is failing, and people with a bicuspid (two-leaflet) aortic valve.

Age
18 Years and older
Sex
All
Disease stage
Severe, symptomatic, degenerative aortic valve stenosis. Heart failure symptoms of NYHA class II, III or IV. Main group: estimated surgical death risk < 3% (low) or ≥ 3% and < 8% (intermediate) at 30 days.
Earlier treatment
Main group: no earlier artificial heart valve or other valve implant. Valve-in-valve group: a failing surgical or catheter-placed biological aortic valve. No heart artery or blood vessel procedure through the skin within 30 days before, except pacemaker or ICD.

Main reasons for not taking part

  • Expected to live less than 2 years (less than 1 year in the bicuspid group)
  • Heart attack within 30 days, or stroke or TIA within 6 months
  • Kidney failure (creatinine > 3.0 mg/dL (265 µmol/L) or eGFR < 30 ml/min/1.73m2) or needing chronic dialysis
  • Weak heart pumping with LVEF < 30%
  • Severe mitral valve leak or narrowing, or untreated coronary artery disease needing a procedure

The registry criteria, word for word

Show all 35 criteriaShow less

Who can take part

  • Subject who is deemed to be at intermediate or low risk for open surgical aortic valve replacement:; Intermediate risk: estimated risk of overall surgical mortality ≥ 3% and < 8% at 30 days; Low risk: estimated risk of overall surgical mortality < 3% at 30 days Estimated risk of overall surgical mortality includes consideration of 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

Who cannot take part

  • 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
  • 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
  • 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)
  • 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.)
  • Hostile Chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk
  • Untreated clinically significant coronary artery disease requiring revascularization
  • 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+)
  • Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position
  • 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
  • Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position; Additional Exclusion Criteria for ViV Cohort
  • Patient has a pre-existing prosthetic heart valve or other implant (such a prosthetic ring with a rigid support structure or transcatheter edge-to-edge repair clip) in any valve position other than aortic
  • 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
  • Renal insufficiency (creatinine > 3.0 mg/dL or eGFR < 30 ml/min/1.73m2) and/or end stage renal disease requiring chronic dialysis
  • Severe ventricular dysfunction with LVEF < 30% as measured by resting echocardiogram
  • Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT)
  • In the opinion of the Investigator, life expectancy is less than 2 years
  • Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT
  • Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis
  • Minimum access vessel diameter of < 5.0 mm for small FlexNav Delivery System and < 5.5 mm for large FlexNav Delivery System
  • Eccentricity ratio of the annulus < 0.73; Additional Exclusion Criteria for Pivotal Randomized Cohort
  • Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT
  • Inadequate aortic valve calcification
  • Failing valve has moderate or greater paravalvular regurgitation
  • Known severe prosthesis-patient mismatch
  • Failing valve is unstable, rocking, or not structurally intact
  • Bioprosthetic valve diameter that would not accommodate implantation of the Navitor Valve
  • Increased risk of coronary obstruction by prosthetic leaflets of the index valve; Additional Exclusion Criteria for bicuspid cohort
  • In the opinion of the Investigator life expectancy is less than 1 year
  • Inadequate or severe aortic valve calcification and/or anatomical features that would preclude safe delivery of the valve

Where in Israel

Also in 12 other countries, 105 sites

  • Shaare Zedek Medical CenterJerusalem, IsraelNo longer taking part
  • Rabin Medical CenterPetah Tikva, IsraelNo longer taking part

About the trial

What the trial wants to find out

The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.

Read full original descriptionShow less

The trial will also evaluate the safety and effectiveness of the Navitor TAVI System in a valve-in-valve (ViV) application in patients with symptomatic heart disease due to failure of a surgical or transcatheter bioprosthetic aortic valve who are at high or greater surgical risk.

In addition, the trial will assess the safety of the Navitor TAVI System for the treatment of symptomatic, severe native aortic stenosis in patients with bicuspid aortic valve anatomy, irrespective of surgical risk classification.

The 2 groups in the trial

  • Navitor Transcatheter Aortic Valve Implantation (TAVI) SystemTreatment being tested

    TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System

  • Any Commercially Available Transcatheter Aortic Valve System (CAV)Existing treatment, for comparison

    TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)

    Treatment: Any Commercially Available Transcatheter Aortic Valve (CAV) System

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients Who Have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement
Plain-language title
Navitor heart valve for people with severe aortic stenosis needing valve replacementGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
11 September 2026