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

Aortic Valve Stenosis Clinical Trial

— ENVISION  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932615
• Other study ID #: ABT-CIP-10487
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2024
• Est. completion date: April 2036

Study information

• Verified date: April 2024
• Source: Abbott Medical Devices
• Contact: Sara Scrivano
• Phone: 623-256-9821
• Email: sara.scrivano[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: April 2036
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis
• Constriction, Pathologic
• Heart Disease Structural Disorder
• Heart Diseases
• Heart Valve Diseases

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.
• 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.

Locations

Country	Name	City	State
United States	Mission Health & Hospitals	Asheville	North Carolina
United States	Ascension Texas Cardiovascular	Austin	Texas
United States	Buffalo General Hospital	Buffalo	New York
United States	Christ Hospital	Cincinnati	Ohio
United States	The Cleveland Clinic	Cleveland	Ohio
United States	The Methodist Hospital	Houston	Texas
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Pinnacle Health System	Mechanicsburg	Pennsylvania
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Atlantic Health System - Morristown Memorial Hospital	Morristown	New Jersey
United States	Columbia University Medical Center/NYPH	New York	New York
United States	Montefiore Medical Center - Moses Division	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Los Robles Regional Medical Center	Thousand Oaks	California
United States	Washington Hospital Center	Washington	District of Columbia
United States	Aspirus Wausau Hospital	Wausau	Wisconsin
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause mortality or all stroke	Number of patients that had any of the outcome events.	At 12 months post-procedure