ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
Public ClinicalTrials.gov record NCT05932615. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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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
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05932615
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,500 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 15, 2024 (Actual)
- Primary completion
- Apr 2027 (Estimated)
- Completion
- Apr 2036 (Estimated)
- Last update posted
- Sep 11, 2026
2024 – 2036
United States locations
- U.S. sites
- 74
- U.S. states
- 35
- U.S. cities
- 68
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Hospital - Univ. of Alabama at Birmingham (UAB) | Birmingham | Alabama | 35233 | — |
| St. Joseph's Hospital & Medical Center | Phoenix | Arizona | 85013 | — |
| Tucson Medical Center | Tucson | Arizona | 85712 | — |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | — |
| Kaiser Permanente Fontana Medical Center | Fontana | California | 92335 | — |
| Southern California Permanente Medical Group - La Jolla | La Jolla | California | 92037 | — |
| University of California at San Francisco | San Francisco | California | 94143 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| Los Robles Regional Medical Center | Thousand Oaks | California | 91360 | — |
| St. Joseph's Hospital & Medical Center | Denver | Colorado | 80218 | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| HCA Florida - JFK Hospital | Atlantis | Florida | 33462 | — |
| HCA Florida Largo Hospital | Largo | Florida | 33770 | — |
| Baptist Hospital of Miami | Miami | Florida | 33176 | — |
| Naples Comprehensive Health | Naples | Florida | 34102 | — |
| HCA Florida Ocala Hospital | Ocala | Florida | 34471 | — |
| AdventHealth Orlando | Orlando | Florida | 32825 | — |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | — |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | — |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | — |
| The Queen's Medical Center | Honolulu | Hawaii | 96814 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Endeavor Health | Evanston | Illinois | 60201 | — |
| Northwestern Memorial Hospital | Evanston | Illinois | 60201 | — |
| Ascension St. Vincent | Indianapolis | Indiana | 46290 | — |
| Ascension Via Christi Hospitals Wichita | Wichita | Kansas | 67226 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| MedStar Union Memorial Hospital | Baltimore | Maryland | 21218 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Massachusetts Medical Center | Worcester | Massachusetts | 01655 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Western Michigan Univ. Homer Stryker M.D. School of Medicine | Kalamazoo | Michigan | 49048 | — |
| MyMichigan Medical Center Midland | Midland | Michigan | 48670 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Virtua Our Lady of Lourdes Hospital | Camden | New Jersey | 08103 | — |
| Englewood Hospital & Medical Center | Englewood | New Jersey | 076960 | — |
| Morristown Medical Center | Morristown | New Jersey | 07962 | — |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | — |
| AtlantiCare Regional Medical Center - Mainland Campus | Pomona | New Jersey | 08240 | — |
| Presbyterian Hospital | Albuquerque | New Mexico | 87106 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| Columbia University Medical Center/NYPH | New York | New York | 10032 | — |
| Montefiore Medical Center (Main Campus and White Plains Hospital) | New York | New York | 10467 | — |
| St. Francis Hospital | Roslyn | New York | 11576 | — |
| Mission Hospital | Asheville | North Carolina | 28801 | — |
| East Carolina Heart Institute | Greenville | North Carolina | 27834 | — |
| The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio Health Research Institute | Columbus | Ohio | 43113 | — |
| Hillcrest Medical Center | Tulsa | Oklahoma | 74104 | — |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | — |
| Pinnacle Health System | Mechanicsburg | Pennsylvania | 17055 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Allegheny General Hospital - ASRI | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | — |
| Lankenau Institute for Medical Research | Wynnewood | Pennsylvania | 19096 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| North Central Heart | Sioux Falls | South Dakota | 57108 | — |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Ascension Texas Cardiovascular | Austin | Texas | 78705 | — |
| Austin Heart | Austin | Texas | 78756 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Houston Methodist | Houston | Texas | 77030 | — |
| UTHealth Memorial Hermann | Houston | Texas | 77030 | — |
| Baylor Scott & White - The Heart Hospital Plano | Plano | Texas | 75093 | — |
| Intermountain Health St George Regional Hospital (Main Campus and IMC Murray) | St. George | Utah | 84790 | — |
| University of Virginia Medical Center (Main Campus and Riverside Regional Medical Center Location) | Charlottesville | Virginia | 22908 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
| Aurora Medical Group | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05932615, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 11, 2026 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05932615 live on ClinicalTrials.gov.