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

Study acronym: ENVISION
StatusEnrolling by Invitation
PhaseNot applicable
Started2024-03-15
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
Study Status, Contacts/Locations v12
Trial sites expanded: 84 → 107 locations
2026-05-05
Study Status, Oversight, Study Description, Eligibility, Contacts/Locations v11
Study sites66→84
Eligibility criteria+243 characters
[...] ronary obstruction by prosthetic leaflets of the index valve Additional Exclusion Criteria for bicuspid cohort In the opinion of the Investigator life expectancy is less than 1 year Inadequate or severe aortic valve calcification and/or anatomical features that would preclude safe delivery of the valve
Study description+356 characters
ENVISION is a prospective, multi-center clinical investigation at up to 115135 sites globally. The objective of this clinical investigatio [...] for surgical mortality. The trial will register subjects in twothree separate cohorts: (1) a pivotal randomized cohort and, (2) a valve-in-valve (ViV) cohort and (3) a bicuspid cohort. The objective of the pivotal randomized cohort is to evalu [...] or surgical mortality. The Randomization Cohort will enroll approxmatly1500approximately 1500 subjects and will be randomized between the Navitor TAVI Im [...] alve-in-Transcatheter Aortic Valve replacement (TAV-in-TAV). The b [...]
2025-10-08
Study Status, Contacts/Locations v10
Study sites61→66
2025-09-30
Study Status, Oversight, Contacts/Locations v9
Study sites60→61
2025-07-08
Study Status, Oversight, Study Description, Eligibility, Contacts/Locations v8
Study sites62→60
Eligibility criteria+1,231 characters
[...] Nav Delivery System Eccentricity ratio of the annulus < 0.73 Additional Exclusion Criteria for Pivotal Randomized Cohort Hostile Chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would [...]
Study description+833 characters
ENVISION is a prospective, randomized controlled, multi-center clinical investigation that will randomize approximately 1500 subjects at up to 95115 sites globally. The objective of this clinical investigatio [...] considered intermediate or low risk for surgical mortality. SubjectsThe trial will register subjects in thistwo clinicalseparate investigationcohorts: (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 nativ [...] [...]
Show 7 earlier versions
2025-05-06
Study Status, Oversight, Contacts/Locations v7
Study sites62 entries, revised
ScrippsSt. Health NorthshoreJoseph's UniversityHospital HealthSystem Cardiovascular Research Institute of Kansas Catholic& Medical Center Buffalo General Hospital Providence St. VincentJoseph's Hospital & Medical Center AspirusEndeavor WausauHealth Northwestern Memorial Hospital Via Christi Regional Medical Center - St. Francis Campus Borgess Medical Center Hillcrest Medical Center
2025-02-07
Study Status, Contacts/Locations v6
Re-verified, no change to tracked fields
2024-08-13
Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v5
Trial statusRecruiting→Enrolling by Invitation
Start date2024-03-19→2024-03-15
Study sites21→62
2024-04-29
Study Status, Contacts/Locations v4
Study sites18→21
2024-03-29
Not Yet Recruiting→Recruiting Study Status, Study Description, Study Design, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11→confirmed 2024-03-19
Enrollment target1300→1500
Study sites5→18
Study description-6 characters
ENVISION is a prospective, randomized controlled, multi-center clinical investigation that will randomize upapproximately to 13001500 subjects at up to 8095 sites in the U.S. and Canadaglobally. The objective of this clinical investigation is to evaluat [...]
2023-10-21
Withheld→Not Yet Recruiting Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v2
Trial statusWithheld→Not Yet Recruiting
Primary completion datenot stated→2027-04
Completion datenot stated→2036-04
Start datenot stated→2023-11
Lead sponsor[Redacted]→Abbott Medical Devices
Study title+33 characters
[ENVISION IDE Trial: Safety and Effectiveness of deviceNAVITOR thatin isTranscatheter notAortic approvedValve or cleared by the U.S. FDA]Implantation
2023-10-12
Study Status v1
Re-verified, no change to tracked fields
2023-07-05
Original filing
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. In addition, the trial will assess the safety of the Navitor TAVI System for the treatment of symptomatic, severe native aortic stenosis in patients with bicuspid aortic valve anatomy, irrespective of surgical risk classification.
Trial Details
NCT Number NCT05932615
Lead Sponsor Abbott Medical Devices
Conditions Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
Enrollment 1,500 participants
Start Date 2024-03-15
Primary Completion 2027-04 (estimated)
Study Completion 2036-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-11