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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 2, 2024
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE June 27, 2023
First Posted Date  ICMJE July 6, 2023
Last Update Posted Date April 2, 2024
Actual Study Start Date  ICMJE March 19, 2024
Estimated Primary Completion Date April 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2023)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
Official Title  ICMJE Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients Who Have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aortic Valve Stenosis
  • Heart Valve Diseases
  • Aortic Valve Disease
  • Heart Disease Structural Disorder
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Navitor Transcatheter Aortic Valve Implantation (TAVI) System
    TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System
    Intervention: Device: Navitor Transcatheter Aortic Valve Implantation (TAVI) System
  • Active Comparator: Any Commercially Available Transcatheter Aortic Valve System (CAV)
    TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)
    Intervention: Device: Any Commercially Available Transcatheter Aortic Valve (CAV) System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2024)
1500
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE April 2036
Estimated Primary Completion Date April 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sara Scrivano 623-256-9821 sara.scrivano@abbott.com
Contact: Alicia Kimber 415-917-9696 alicia.kimber@abbott.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05932615
Other Study ID Numbers  ICMJE ABT-CIP-10487
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available to other researhers.
Current Responsible Party Abbott Medical Devices
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE Abbott Medical Devices
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Abbott Medical Devices
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP