Clinical trial NCT05932615: ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Aortic Valve Stenosis
Heart Valve Diseases
Aortic Valve Disease
Heart Disease Structural Disorder
Keywords: NAVITOR
Heart disease
Transcatheter aortic valve implantation (TAVI)
Aortic stenosis
Cardiovascular diseases
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: ENVISION is a prospective, randomized controlled, multi-center clinical investigation that will randomize approximately 1500 subjects at up to 95 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. Subjects in this clinical investigation 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.

Eligibility criteria: Key Inclusion Criteria:

1. Subject who is deemed to be at intermediate or low risk for open surgical aortic valve replacement:

   1. Intermediate risk: estimated risk of overall surgical mortality ≥ 3% and \< 8% at 30 days
   2. 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
2. New York Heart Association (NYHA) Functional Classification of II, III, or IV
3. Degenerative aortic valve stenosis

Key Exclusion Criteria:

1. In the opinion of the Investigator, life expectancy is less than 2 years
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 unicuspid or 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
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
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

Primary outcomes:
measure: Composite of all-cause mortality or all stroke
timeFrame: At 12 months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Fontana
country: United States
facility: Kaiser Permanente Fontana Medical Center
state: California
city: La Jolla
country: United States
facility: Southern California Permanente Medical Group - La Jolla
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Denver
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Largo
country: United States
facility: Largo Medical Center
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Evanston
country: United States
facility: Endeavor Health
state: Illinois
city: Evanston
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Wichita
country: United States
facility: Via Christi Regional Medical Center - St. Francis Campus
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Midland
country: United States
facility: MyMichigan Medical Center Midland
state: Michigan
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Morristown
country: United States
facility: Atlantic Health System - Morristown Memorial Hospital
state: New Jersey
city: Mineola
country: United States
facility: Winthrop-University Hospital
state: New York
city: New York
country: United States
facility: New York University Langone Medical Center - Tisch Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: New York
country: United States
facility: Montefiore Medical Center - Moses Division
state: New York
city: Asheville
country: United States
facility: Mission Health & Hospitals
state: North Carolina
city: Greenville
country: United States
facility: East Carolina Heart Institute
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Tulsa
country: United States
facility: Hillcrest Medical Center
state: Oklahoma
city: Mechanicsburg
country: United States
facility: Pinnacle Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Sioux Falls
country: United States
facility: North Central Heart
state: South Dakota
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Ascension Texas Cardiovascular
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Saint George
country: United States
facility: Intermountain St. George Regional Hospital
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)
state: Quebec
city: Montréal
country: Canada
facility: The Royal Victoria Hospital
state: Quebec
city: Calgary
country: Canada
facility: Foothills Medical Centre
city: Saint John
country: Canada
facility: Saint John Regional Hospital - New Brunswick Heart Centre
Study officials:
affiliation: Abbott Structural Heart
name: Barathi Sethuraman
role: STUDY_DIRECTOR
affiliation: The Methodist Hospital Research Institute
name: Michael Reardon, MD
role: STUDY_CHAIR
affiliation: Montefiore Medical Center
name: Azeem Azeem, MD
role: STUDY_CHAIR
affiliation: Cardiovascular Research Institute of Kansas
name: Bassem Chehab, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Pittsburgh Medical Center
name: Ibrahim Sultan, MD
role: PRINCIPAL_INVESTIGATOR
References: