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ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation (ENVISION)

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ClinicalTrials.gov Identifier: NCT05932615
Recruitment Status : Recruiting
First Posted : July 6, 2023
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Heart Valve Diseases Aortic Valve Disease Heart Disease Structural Disorder Device: Navitor Transcatheter Aortic Valve Implantation (TAVI) System Device: Any Commercially Available Transcatheter Aortic Valve (CAV) System Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 19, 2024
Estimated Primary Completion Date : April 2027
Estimated Study Completion Date : April 2036

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Navitor Transcatheter Aortic Valve Implantation (TAVI) System
TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System
 Device: Navitor Transcatheter Aortic Valve Implantation (TAVI) System
TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.
Active Comparator: Any Commercially Available Transcatheter Aortic Valve System (CAV)
TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)
 Device: Any Commercially Available Transcatheter Aortic Valve (CAV) System
TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.


Outcome Measures
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Primary Outcome Measures :
  1. Composite of all-cause mortality or all stroke [ Time Frame: At 12 months post-procedure ]
    Number of patients that had any of the outcome events.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05932615


Contacts
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Contact: Sara Scrivano 623-256-9821 sara.scrivano@abbott.com
Contact: Alicia Kimber 415-917-9696 alicia.kimber@abbott.com

Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Vinny Podichetty Abbott Structural Heart
Study Chair: Michael Reardon, MD The Methodist Hospital Research Institute
Study Chair: Azeem Azeem, MD Montefiore Medical Center
Principal Investigator: Bassem Chehab, MD Cardiovascular Research Institute of Kansas
Principal Investigator: Ibrahim Sultan, MD The University of Pittsburgh Medical Center
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT05932615    
Other Study ID Numbers: ABT-CIP-10487
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: April 30, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available to other researhers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Abbott Medical Devices:
NAVITOR
Heart disease
Transcatheter aortic valve implantation (TAVI)
Aortic stenosis
Cardiovascular diseases
Additional relevant MeSH terms:
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Heart Diseases
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Constriction, Pathologic
Cardiovascular Diseases
Pathological Conditions, Anatomical
Ventricular Outflow Obstruction