The trial is taking place at:
A

Ascension | Ascension Texas Cardiovascular

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

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Abbott

Status

Enrolling

Conditions

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

Treatments

Device: Navitor Transcatheter Aortic Valve Implantation (TAVI) System
Device: Any Commercially Available Transcatheter Aortic Valve (CAV) System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05932615
ABT-CIP-10487

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

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

Key Exclusion Criteria:

  • In the opinion of the Investigator, life expectancy is less than 2 years
  • 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
  • Untreated clinically significant coronary artery disease requiring revascularization
  • 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
  • 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
  • Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
  • Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
  • Renal insufficiency (creatinine > 3.0 mg/dL or eGFR < 30 ml/min/1.73m2) and/or end stage renal disease requiring chronic dialysis
  • 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.)
  • Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk
  • Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+)
  • Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT.
  • Severe ventricular dysfunction with LVEF < 30% as measured by resting echocardiogram
  • Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position
  • Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT)
  • Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis
  • Minimum access vessel diameter of < 5.0 mm for small FlexNav Delivery System and < 5.5 mm for large FlexNav Delivery System
  • Eccentricity ratio of the annulus < 0.73

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,500 participants in 2 patient groups

Navitor Transcatheter Aortic Valve Implantation (TAVI) System
Experimental group
Description:
TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System
Treatment:
Device: Navitor Transcatheter Aortic Valve Implantation (TAVI) System
Any Commercially Available Transcatheter Aortic Valve System (CAV)
Active Comparator group
Description:
TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)
Treatment:
Device: Any Commercially Available Transcatheter Aortic Valve (CAV) System

Trial contacts and locations

21

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Central trial contact

Sara Scrivano; Alicia Kimber

Data sourced from clinicaltrials.gov

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