Trial Outcomes & Findings for Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation (NCT NCT04788888)
NCT ID: NCT04788888
Last Updated: 2026-04-13
Results Overview
The primary effectiveness endpoint is moderate or greater paravalvular leak (PVL) at 30 days, as assessed by the echocardiographic core laboratory. The hypothesis test was performed based on the implanted population in whom a functional Navitor valve remained implanted at 30 days.
ACTIVE_NOT_RECRUITING
NA
434 participants
at 30 Days
2026-04-13
Participant Flow
A total of 434 primary analysis subjects were registered between July 13, 2021 and November 27, 2024.
Participant milestones
| Measure |
Primary Analysis Cohort
Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+)
Navitor Transcatheter Aortic Valve and FlexNav Delivery System: Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.
|
|---|---|
|
Overall Study
STARTED
|
434
|
|
Overall Study
COMPLETED
|
341
|
|
Overall Study
NOT COMPLETED
|
93
|
Reasons for withdrawal
| Measure |
Primary Analysis Cohort
Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+)
Navitor Transcatheter Aortic Valve and FlexNav Delivery System: Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Missed or Overdue Visits
|
1
|
|
Overall Study
Pending visit
|
14
|
|
Overall Study
Have not reached lower window limit of 12-month follow-up visit
|
67
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Primary Analysis Cohort
n=434 Participants
Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+)
Navitor Transcatheter Aortic Valve and FlexNav Delivery System: Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.
|
|---|---|
|
Region of Enrollment
Israel
|
4 participants
n=434 Participants
|
|
Region of Enrollment
Australia
|
70 participants
n=434 Participants
|
|
Age, Continuous
|
77.2 years
STANDARD_DEVIATION 4.0 • n=434 Participants
|
|
Sex: Female, Male
Female
|
217 Participants
n=434 Participants
|
|
Sex: Female, Male
Male
|
217 Participants
n=434 Participants
|
|
Region of Enrollment
Europe
|
360 participants
n=434 Participants
|
|
New York Heart Association functional classification (NYHA Class)
Class I
|
0 Participants
n=434 Participants
|
|
New York Heart Association functional classification (NYHA Class)
Class II
|
329 Participants
n=434 Participants
|
|
New York Heart Association functional classification (NYHA Class)
Class III
|
105 Participants
n=434 Participants
|
|
New York Heart Association functional classification (NYHA Class)
Class IV
|
0 Participants
n=434 Participants
|
PRIMARY outcome
Timeframe: at 30 DaysPopulation: The analysis population includes the implanted population (IP) in whom a functional Navitor valve remained implanted at 30 days post index Navitor implantation procedure.
The primary effectiveness endpoint is moderate or greater paravalvular leak (PVL) at 30 days, as assessed by the echocardiographic core laboratory. The hypothesis test was performed based on the implanted population in whom a functional Navitor valve remained implanted at 30 days.
Outcome measures
| Measure |
Primary Analysis Cohort
n=418 Participants
Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+)
Navitor Transcatheter Aortic Valve and FlexNav Delivery System: Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.
|
|---|---|
|
Primary Effectiveness Endpoint: Percentage of Participants With Moderate or Greater Paravalvular Leak (PVL)
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: at 12 monthsPopulation: The attempted population (AP) includes all registered subjects (subjects attempted with Navitor valve implantation, defined as the insertion of the FlexNav delivery system into the subject's vasculature).
The composite of rate of all-cause mortality or fatal stroke/stroke with disability at 12 months post index Navitor implantation procedure as adjudicated by the CEC per Valve Academic Research Consortium (VARC-3) definitions calculated against the performance goal of 11.3%.
Outcome measures
| Measure |
Primary Analysis Cohort
n=262 Participants
Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+)
Navitor Transcatheter Aortic Valve and FlexNav Delivery System: Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.
|
|---|---|
|
Primary Safety Endpoint: The Rates of All-cause Mortality or Fatal Stroke/Stroke With Disability
|
2.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: This secondary endpoint was assessed in the implanted population in whom a functional Navitor valve remained implanted at 12 months. Number of subjects analyzed for each secondary endpoint reflects those with paired data available at both baseline and the 12-month follow-up visit.
This endpoint was evaluated by comparing the mean paired difference in mean transvalvular gradient from baseline to 12 months against the performance goal of -10mmHg.
Outcome measures
| Measure |
Primary Analysis Cohort
n=242 Participants
Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+)
Navitor Transcatheter Aortic Valve and FlexNav Delivery System: Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.
|
|---|---|
|
Mean Change in Mean Transvalvular Gradient
Baseline
|
42.8 mmHg
Standard Deviation 11.2
|
|
Mean Change in Mean Transvalvular Gradient
12 months
|
8.0 mmHg
Standard Deviation 4.6
|
|
Mean Change in Mean Transvalvular Gradient
Change between baseline and 12 months
|
-34.8 mmHg
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline to12 monthsPopulation: This secondary endpoint was assessed in the implanted population in whom a functional Navitor valve remained implanted at 12 months. Number of subjects analyzed for each secondary endpoint reflects those with paired data available at both baseline and the 12-month follow-up visit.
This endpoint was evaluated by comparing the mean paired difference in effective orifice area (EOA) from baseline to 12 months against the performance goal of 0.4 cm².
Outcome measures
| Measure |
Primary Analysis Cohort
n=199 Participants
Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+)
Navitor Transcatheter Aortic Valve and FlexNav Delivery System: Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.
|
|---|---|
|
Mean Change in Effective Orifice Area (EOA)
Baseline
|
0.8 cm²
Standard Error 0.2
|
|
Mean Change in Effective Orifice Area (EOA)
12 months
|
1.9 cm²
Standard Error 0.5
|
|
Mean Change in Effective Orifice Area (EOA)
Change between baseline and 12 months
|
1.1 cm²
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: This secondary endpoint was assessed in the attempted population. Number of subjects analyzed for each secondary endpoint reflects those with paired data available at both baseline and the 12-month follow-up visit.
This endpoint was evaluated by comparing the mean paired difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL) score from baseline to 12 months against the performance goal of 5 points. Higher KCCQ scores indicate better symptoms and physical functioning. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a tool of heart failure-specific health status questionnaire. Score ranges from 0 to 100, where 0 represents the worst and 100 represents the best quality of life. Higher scores indicate better quality of life and lower symptoms. The mean change from baseline reflects the average improvement (positive values) or worsening (negative values) in patient-reported health status.
Outcome measures
| Measure |
Primary Analysis Cohort
n=251 Participants
Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+)
Navitor Transcatheter Aortic Valve and FlexNav Delivery System: Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.
|
|---|---|
|
Mean Change In KCCQ Quality Of Life Score
12 months
|
86.1 score on a scale
Standard Deviation 19.5
|
|
Mean Change In KCCQ Quality Of Life Score
Baseline
|
70.6 score on a scale
Standard Deviation 22.2
|
|
Mean Change In KCCQ Quality Of Life Score
Change between baseline and 12 months
|
15.5 score on a scale
Standard Deviation 22.5
|
Adverse Events
Primary Analyis Cohort
Serious adverse events
| Measure |
Primary Analyis Cohort
n=434 participants at risk
Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+)
Navitor Transcatheter Aortic Valve and FlexNav Delivery System: Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
10/434 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
5/434 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
1.4%
6/434 • 1 year
|
|
Cardiac disorders
Atrial Fibrillation
|
4.8%
21/434 • 1 year
|
|
Cardiac disorders
Atrioventricular Block Complete
|
15.9%
69/434 • 1 year
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
1.2%
5/434 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.92%
4/434 • 1 year
|
|
Cardiac disorders
Bundle Branch Block Left
|
3.2%
14/434 • 1 year
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.23%
1/434 • 1 year
|
|
Cardiac disorders
Cardiac Failure
|
0.69%
3/434 • 1 year
|
|
Cardiac disorders
Myocardial Infarction
|
0.46%
2/434 • 1 year
|
|
Cardiac disorders
Pericardial Effusion
|
0.23%
1/434 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.69%
3/434 • 1 year
|
|
General disorders
Paravalvular Regurgitation
|
0.23%
1/434 • 1 year
|
|
General disorders
Prosthetic Cardiac Valve Thrombosis
|
0.69%
3/434 • 1 year
|
|
General disorders
Sudden Death
|
0.23%
1/434 • 1 year
|
|
Infections and infestations
Endocarditis
|
0.46%
2/434 • 1 year
|
|
Injury, poisoning and procedural complications
Post Procedural Haematuria
|
0.23%
1/434 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
0.46%
2/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Complication
|
0.23%
1/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Dissection
|
0.46%
2/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haematoma
|
0.69%
3/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haemorrhage
|
1.6%
7/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Occlusion
|
0.92%
4/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
2.1%
9/434 • 1 year
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.23%
1/434 • 1 year
|
|
Nervous system disorders
Ischaemic Stroke
|
1.6%
7/434 • 1 year
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.92%
4/434 • 1 year
|
|
Product Issues
Device Dislocation
|
0.46%
2/434 • 1 year
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.2%
5/434 • 1 year
|
|
Renal and urinary disorders
Renal Failure
|
0.23%
1/434 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
5/434 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.69%
3/434 • 1 year
|
|
Vascular disorders
Aortic Dissection
|
0.23%
1/434 • 1 year
|
|
Vascular disorders
Hypertension
|
0.46%
2/434 • 1 year
|
|
Vascular disorders
Hypotension
|
0.46%
2/434 • 1 year
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
1.6%
7/434 • 1 year
|
|
Cardiac disorders
Sinus Bradycardia
|
0.23%
1/434 • 1 year
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.6%
7/434 • 1 year
|
|
Gastrointestinal disorders
Upper gastrointestinal Haemorrhage
|
0.23%
1/434 • 1 year
|
Other adverse events
| Measure |
Primary Analyis Cohort
n=434 participants at risk
Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+)
Navitor Transcatheter Aortic Valve and FlexNav Delivery System: Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
2.5%
11/434 • 1 year
|
|
Cardiac disorders
Atrioventricular Block Complete
|
2.1%
9/434 • 1 year
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
9.9%
43/434 • 1 year
|
|
Cardiac disorders
Bradycardia
|
1.8%
8/434 • 1 year
|
|
Cardiac disorders
Bundle Branch Block Left
|
41.2%
179/434 • 1 year
|
|
Cardiac disorders
Bundle Branch Block Right
|
1.8%
8/434 • 1 year
|
|
Cardiac disorders
Cardiac Failure
|
0.69%
3/434 • 1 year
|
|
Cardiac disorders
Pericardial Effusion
|
0.69%
3/434 • 1 year
|
|
General disorders
Chest Pain
|
2.1%
9/434 • 1 year
|
|
General disorders
Paravalvular Regurgitation
|
1.8%
8/434 • 1 year
|
|
General disorders
Prosthetic Cardiac Valve Thrombosis
|
0.23%
1/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Bruising
|
0.23%
1/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Complication
|
0.23%
1/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Discharge
|
0.23%
1/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Ecchymosis
|
0.23%
1/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haematoma
|
2.1%
9/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haemorrhage
|
1.8%
8/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Pain
|
0.23%
1/434 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Pseudoaneurysm
|
0.23%
1/434 • 1 year
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.46%
2/434 • 1 year
|
|
Product Issues
Device Dislocation
|
0.92%
4/434 • 1 year
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.69%
3/434 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.23%
1/434 • 1 year
|
|
Renal and urinary disorders
Renal Failure
|
0.46%
2/434 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
0.23%
1/434 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.23%
1/434 • 1 year
|
|
Vascular disorders
Groin Haematoma
|
0.23%
1/434 • 1 year
|
|
Vascular disorders
Hypertension
|
3.0%
13/434 • 1 year
|
|
Vascular disorders
Hypotension
|
1.2%
5/434 • 1 year
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.69%
3/434 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
5/434 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.6%
7/434 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
2.3%
10/434 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed
- Publication restrictions are in place
Restriction type: OTHER