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

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

Tracking Information

• First Submitted Date: June 27, 2023
• First Posted Date: July 6, 2023
• Last Update Posted Date: April 30, 2024
• Actual Study Start Date: March 19, 2024
• Estimated Primary Completion Date: April 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Aortic Valve Stenosis
• Heart Valve Diseases
• Aortic Valve Disease
• Heart Disease Structural Disorder

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 29, 2024): 1500
• Original Enrollment: Not Provided
• Estimated Study Completion Date: April 2036
• Estimated Primary Completion Date: April 2027 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sara Scrivano; 623-256-9821; sara.scrivano@abbott.com

Contact: Alicia Kimber; 415-917-9696; alicia.kimber@abbott.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05932615
• Other Study ID Numbers: 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

• 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: Abbott Medical Devices
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

Investigators

• 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: April 2024