An interventional study of Navitor Transcatheter Aortic Valve Implantation (TAVI) System and Any Commercially Available Transcatheter Aortic Valve (CAV) System in Aortic Valve Stenosis, Heart Valve Diseases and Aortic Valve Disease, sponsored by Abbott Medical Devices. Enrolling by invitation at 107 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment
Among 26 studies in Aortic Valve Stenosis by Abbott Medical Devices — 4 open to participants now, 9 under way, none of them phase 3. Aortic Valve Stenosis · Abbott Medical Devices.
Among the 26 studies in Aortic Valve Stenosis by Abbott Medical Devices, this one has the largest planned enrollment of the 20 interventional ones that give a count, is one of 2 that started in 2024, is one of 19 with no phase, and was the 21st registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →4 of the 26 studies in Aortic Valve Stenosis by Abbott Medical Devices are open now, in 12 countries. Each count lists the studies.
Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2024.
Median enrollment 150 across the 20 interventional studies, 215 across the 6 observational. Of the 15 that completed or were terminated, 10 (67%) have results posted.
Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
3 of the studies in Aortic Valve Stenosis by Abbott Medical Devices that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05932615Abbott Medical DevicesENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation | 2027-04 |
| NCT06008080Abbott Medical DevicesPost-Market Clinical Follow Up Study With Navitor Valve | 2027-07 |
| NCT07082426Abbott Medical DevicesEarly System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study | 2027-08-30 |
Among the 26 studies in Aortic Valve Stenosis by Abbott Medical Devices, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
ENVISION is a prospective, multi-center clinical investigation at up to 135 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 three separate cohorts: (1) a pivotal randomized cohort, (2) a valve-in-valve (ViV) cohort and (3) a bicuspid 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 approximately 1500 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).
The bicuspid cohort will be conducted as a separate, prospective multicenter, open label study within the ENVISION IDE trial. A total of 250 symptomatic, severe aortic stenosis subjects with bicuspid aortic valve anatomy who are deemed suitable for transcatheter aortic valve implantation with a Navitor valve will be enrolled.
Key Inclusion Criteria:
Subject who is deemed to be at intermediate or low risk for open surgical aortic valve replacement:
Key Exclusion Criteria:
Additional Exclusion Criteria for Pivotal Randomized Cohort
Additional Exclusion Criteria for ViV Cohort
Additional Exclusion Criteria for bicuspid cohort
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System
Device: Navitor Transcatheter Aortic Valve Implantation (TAVI) System
TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)
Device: 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.
TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.
Composite of all-cause mortality or all stroke
Number of patients that had any of the outcome events.
Time frame: At 12 months post-procedure
Showing the first 100 of 107 sites across 13 countries. Choose a country and city above to see the rest.
Plan to share: No — There is not a plan to make IPD available to other researhers.
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Apr 2027, 37 months after the start.
Of 111 industry-sponsored interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 54. This study's planned 37 months is above that.
Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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