Aortic Valve StenosisENVISIONNCT05932615
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
A study testing Navitor Transcatheter Aortic Valve Implantation (TAVI) System and Any Commercially Available Transcatheter Aortic Valve (CAV) System in people with Aortic Valve Stenosis and Heart Valve Diseases, run by Abbott Medical Devices at 107 sites in 13 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease
- What is being tested?
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System and Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 107 sitesin 13 countries
- Study dates
- 15 Mar 2024to Apr 2036
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- In the opinion of the Investigator, life expectancy is less than 2 years
- 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
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- 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 unicuspid or 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
- 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 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
- Hostile Chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk
- 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 valve is a unicuspid or bicuspid valve as verified by echocardiography or CT
- Inadequate aortic valve calcification
- 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
- Failing valve has moderate or greater paravalvular regurgitation.
- Known severe prosthesis-patient mismatch
- Failing valve is unstable, rocking, or not structurally intact.
- 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.
- 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
Trial locations and contacts
107 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
107 sites in 13 countries
United States74 sites
Presbyterian Hospital
Albuquerque, New Mexico, 87106
University of Michigan
Ann Arbor, Michigan, 48109
Mission Hospital
Asheville, North Carolina, 28801
Piedmont Heart Institute
Atlanta, Georgia, 30309
HCA Florida - JFK Hospital
Atlantis, Florida, 33462
Ascension Texas Cardiovascular
Austin, Texas, 78705
Austin Heart
Austin, Texas, 78756
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey, 08103
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia Medical Center (Main Campus and Riverside Regional Medical Center Location)
Charlottesville, Virginia, 22908
University of Chicago Medical Center
Chicago, Illinois, 60637
The Christ Hospital
Cincinnati, Ohio, 45219
The Cleveland Clinic
Cleveland, Ohio, 44195
Ohio Health Research Institute
Columbus, Ohio, 43113
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
St. Joseph's Hospital & Medical Center
Denver, Colorado, 80218
Henry Ford Hospital
Detroit, Michigan, 48202
Englewood Hospital & Medical Center
Englewood, New Jersey, 076960
Endeavor Health
Evanston, Illinois, 60201
Northwestern Memorial Hospital
Evanston, Illinois, 60201
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
East Carolina Heart Institute
Greenville, North Carolina, 27834
The Queen's Medical Center
Honolulu, Hawaii, 96814
Houston Methodist
Houston, Texas, 77030
UTHealth Memorial Hermann
Houston, Texas, 77030
Ascension St. Vincent
Indianapolis, Indiana, 46290
Western Michigan Univ. Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, 49048
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Southern California Permanente Medical Group - La Jolla
La Jolla, California, 92037
HCA Florida Largo Hospital
Largo, Florida, 33770
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Pinnacle Health System
Mechanicsburg, Pennsylvania, 17055
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Baptist Hospital of Miami
Miami, Florida, 33176
MyMichigan Medical Center Midland
Midland, Michigan, 48670
Aurora Medical Group
Milwaukee, Wisconsin, 53215
West Virginia University
Morgantown, West Virginia, 26506
Morristown Medical Center
Morristown, New Jersey, 07962
Naples Comprehensive Health
Naples, Florida, 34102
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Ochsner Medical Center
New Orleans, Louisiana, 70121
Mount Sinai Hospital
New York, New York, 10029
Columbia University Medical Center/NYPH
New York, New York, 10032
Montefiore Medical Center (Main Campus and White Plains Hospital)
New York, New York, 10467
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
HCA Florida Ocala Hospital
Ocala, Florida, 34471
AdventHealth Orlando
Orlando, Florida, 32825
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Baylor Scott & White - The Heart Hospital Plano
Plano, Texas, 75093
AtlantiCare Regional Medical Center - Mainland Campus
Pomona, New Jersey, 08240
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Mayo Clinic
Rochester, Minnesota, 55905
St. Francis Hospital
Roslyn, New York, 11576
University of California at San Francisco
San Francisco, California, 94143
Swedish Medical Center
Seattle, Washington, 98122
North Central Heart
Sioux Falls, South Dakota, 57108
Intermountain Health St George Regional Hospital (Main Campus and IMC Murray)
St. George, Utah, 84790
Stanford University Medical Center
Stanford, California, 94305
Tallahassee Research Institute
Tallahassee, Florida, 32308
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Tucson Medical Center
Tucson, Arizona, 85712
Hillcrest Medical Center
Tulsa, Oklahoma, 74104
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67226
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
Germany7 sites
Kerckhoff-Klinik gGmbH
Bad Nauheim
Medizinische Einrichtungen der Universität zu Koln
Cologne
St.-Johannes Hospital
Dortmund, N. RHIN, 44137
Klinikum der Johann Wolfgang Goethe-Universitat Frankfurt
Frankfurt
Universitatsklinikum Schleswig-Holstein - Campus Kiel
Kiel
TUM Klinikum - Deutsches Herzzentrum Munchen
München
Universitatsklinikum Ulm
Ulm
Canada6 sites
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, H1T 1C8
MUHC - The Royal Victoria Hospital
Montreal, Quebec, H4A3J1
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Saint John Regional Hospital - New Brunswick Heart Centre
Saint John, NB E2L 4L4
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
St. Paul's Hospital
Vancouver, British Columbia, V6E 1M7
Australia4 sites
Royal Adelaide Hospital
Adelaide, Saustrl, 5000
Monash Health
Clayton, Victoria, 3168
The Alfred Hospital
Melbourne, Victoria, 3004
John Hunter Hospital
Newcastle, New South Wales, 2300
United Kingdom4 sites
The Royal Sussex County Hospital
Brighton
King's College Hospital
London
St. Bartholomew's Hospital
London
Freeman Hospital
Newcastle upon Tyne
France3 sites
Hopital Haut Leveque
Pessac, AQT, 33600
CHU Rennes, Pontchaillou
Rennes, Brittan, 35033
Clinique Pasteur Toulouse
Toulouse, Midpyre, 31076
Israel2 sites
Shaare Zedek Medical Center
Jerusalem, Jeruslm, 9103102
Rabin Medical Center
Petah Tikva
Sweden2 sites
Sahlgrenska University Hospital - Gothenburg
Gothenburg
Karolinska University Hospital, Solna
Stockholm
Netherlands1 site
Universitair Medisch Centrum Groningen
Groningen, Grogen, 9713 GZ
About this study
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
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.
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.
Read the detailed description
ENVISION is a prospective, multi-center clinical investigation at up to 135 sites globally. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. The trial will register subjects in three separate cohorts: (1) a pivotal randomized cohort, (2) a valve-in-valve (ViV) cohort and (3) a bicuspid cohort.
The objective of the pivotal randomized cohort is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.
The Randomization Cohort will enroll approximately 1500 subjects and will be randomized between the Navitor TAVI Implantation System (test arm) and any commercially available transcatheter aortic valve system (CAV) (control arm) in a 1:1 ratio.
The ViV cohort will be conducted as a separate prospective, multicenter, open label, two-group registry within the ENVISION IDE trial. A total of 250 subjects deemed to be at high or greater risk for open surgical therapy will be enrolled concurrently across two separate groups: 125 subjects undergoing transcatheter Aortic Valve-in-Surgical Aortic Valve replacement (TAV-in-SAV) and 125 subjects undergoing Transcatheter Aortic Valve-in-Transcatheter Aortic Valve replacement (TAV-in-TAV).
The bicuspid cohort will be conducted as a separate, prospective multicenter, open label study within the ENVISION IDE trial. A total of 250 symptomatic, severe aortic stenosis subjects with bicuspid aortic valve anatomy who are deemed suitable for transcatheter aortic valve implantation with a Navitor valve will be enrolled.
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
- Being tested
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Keywords
- NAVITOR, Heart disease, Transcatheter aortic valve implantation (TAVI), Aortic stenosis, Cardiovascular diseases
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navitor Transcatheter Aortic Valve Implantation (TAVI) SystemDevice
TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.
Any Commercially Available Transcatheter Aortic Valve (CAV) SystemDevice
TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Navitor Transcatheter Aortic Valve Implantation (TAVI) System | Experimental | TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System Receives: Device: Navitor Transcatheter Aortic Valve Implantation (TAVI) System |
| Any Commercially Available Transcatheter Aortic Valve System (CAV) | Active comparator | TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV) Receives: Device: Any Commercially Available Transcatheter Aortic Valve (CAV) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality or all stroke
Number of patients that had any of the outcome events.
Measured: At 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start15 Mar 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haresh Sachanandani, Study director, Abbott Structural HeartMichael Reardon, MD, Study chair, The Methodist Hospital Research InstituteAzeem Azeem, MD, Study chair, Montefiore Medical CenterBassem Chehab, MD, Principal investigator, Ascension Via Christi Hospitals WichitaIbrahim Sultan, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932615
- Sponsor's protocol ID
- ABT-CIP-10487
- Acronym
- ENVISION
- Status last verified
- May 2026
- First submitted
- 27 Jun 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is not a plan to make IPD available to other researhers.