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ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation | Clinical Trials | Clareo Health

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

Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients Who Have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement

NCT05932615•Abbott Medical Devices

View on ClinicalTrials.gov

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. The trial will also evaluate the safety and effectiveness of the Navitor TAVI System in a valve-in-valve (ViV) application in patients with symptomatic heart disease due to failure of a surgical or transcatheter bioprosthetic aortic valve who are at high or greater surgical risk.

Detailed Description

ENVISION is a prospective, multi-center clinical investigation at up to 115 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. The trial will register subjects in two separate cohorts: (1) a pivotal randomized cohort and (2) a valve-in-valve (ViV) cohort. The objective of the pivotal randomized cohort 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. The Randomization Cohort will enroll approxmatly1500 subjects and 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. The ViV cohort will be conducted as a separate prospective, multicenter, open label, two-group registry within the ENVISION IDE trial. A total of 250 subjects deemed to be at high or greater risk for open surgical therapy will be enrolled concurrently across two separate groups: 125 subjects undergoing transcatheter Aortic Valve-in-Surgical Aortic Valve replacement (TAV-in-SAV) and 125 subjects undergoing Transcatheter Aortic Valve-in-Transcatheter Aortic Valve replacement (TAV-in-TAV).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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
+20 more criteria

Locations (66)

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Kaiser Permanente Fontana Medical Center

Fontana, California, United States

Southern California Permanente Medical Group - La Jolla

La Jolla, California, United States

University of California at San Francisco

San Francisco, California, United States

Stanford University Medical Center

Stanford, California, United States

Los Robles Regional Medical Center

Thousand Oaks, California, United States

St. Joseph's Hospital & Medical Center

Denver, Colorado, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

HCA Florida - JFK Hospital

Atlantis, Florida, United States

Key Dates

Start Date

March 15, 2024

Primary Completion Date

April 1, 2027

Completion Date

April 1, 2036

Last Updated

October 10, 2025

Enrollment

1,500

ESTIMATED participants

Conditions

Aortic Valve StenosisHeart Valve DiseasesAortic Valve DiseaseHeart Disease Structural Disorder

Interventions

Navitor Transcatheter Aortic Valve Implantation (TAVI) System

DEVICE

Any Commercially Available Transcatheter Aortic Valve (CAV) System

DEVICE

Post-Dilatation Effect on TAVI Prostheses Expansion

NCT07477002

Aortic Valve Stenosis

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RECRUITING

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

NCT07366671

TAVI(Transcatheter Aortic Valve Implantation)Aortic Valve Disease

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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