Trial Outcomes & Findings for Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System (NCT NCT02276547)
NCT ID: NCT02276547
Last Updated: 2026-07-24
Results Overview
Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
From the time of implant procedure to 30 days or hospital discharge up to 45 days (whichever is later)
Results posted on
2026-07-24
Participant Flow
Participant milestones
| Measure |
Treatment
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Treatment
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
Overall Study
Death
|
19
|
|
Overall Study
Explant
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Data was not collected on 4 treated subjects.
Baseline characteristics by cohort
| Measure |
Treatment
n=27 Participants
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 12.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
18 participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=27 Participants
|
|
NYHA Functional Class
NYHA Functional Class I
|
0 participants
n=27 Participants
|
|
NYHA Functional Class
NYHA Functional Class II
|
0 participants
n=27 Participants
|
|
NYHA Functional Class
NYHA Functional Class III
|
26 participants
n=27 Participants
|
|
NYHA Functional Class
NYHA Functional Class IV
|
1 participants
n=27 Participants
|
|
Predicted Surgical Mortality
|
7.4 Probability Percentage
STANDARD_DEVIATION 3.7 • n=27 Participants
|
|
Ejection Fraction
|
39 Percentage
STANDARD_DEVIATION 8.3 • n=27 Participants
|
|
Mitral Regurgitation Severity
Severe
|
26 Participants
n=27 Participants
|
|
Mitral Regurgitation Severity
Moderate-Severe
|
1 Participants
n=27 Participants
|
|
Diabetes
|
8 Participants
n=27 Participants
|
|
Hypertension
|
22 Participants
n=27 Participants
|
|
Chronic Lung Disease
|
10 Participants
n=27 Participants
|
|
Peripheral Vascular Disease
|
6 Participants
n=27 Participants
|
|
Renal Dysfunction
|
14 Participants
n=23 Participants • Data was not collected on 4 treated subjects.
|
|
Obstructive Coronary Artery Disease
|
18 Participants
n=23 Participants • Data was not collected on 4 treated subjects
|
|
Previous Coronary Artery Bypass
|
9 Participants
n=27 Participants
|
|
Previous Percutaneous Coronary Intervention
|
11 Participants
n=23 Participants • Data was not collected on 4 treated subjects.
|
|
Previous Valve Replacement or Repair
|
7 Participants
n=27 Participants
|
|
Heart Failure
|
27 Participants
n=27 Participants
|
|
Previous Myocardial Infarction
|
12 Participants
n=27 Participants
|
|
Cardiomyopathy
|
16 Participants
n=27 Participants
|
|
Previous Clinically Significant Arrhythmia
|
23 Participants
n=27 Participants
|
|
Prior Pacemaker/ICD/CRT
|
15 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From the time of implant procedure to 30 days or hospital discharge up to 45 days (whichever is later)Population: Analysis population is all participants implanted with the Tiara valve.
Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention
Outcome measures
| Measure |
Treatment
n=27 Participants
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
Freedom From All-cause Mortality and Major Adverse Events
|
19 Participants
|
SECONDARY outcome
Timeframe: 30 days, 90 days, 180 days and annually to five yearsNumber and percentage of subjects with all-cause mortality, disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding and cardiac surgical or transcatheter reintervention
Outcome measures
| Measure |
Treatment
n=27 Participants
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention
30 Days - Number of participants with all cause mortality or major event · 5 Years
|
8 Participants
|
|
Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention
90 Days - Number of participants with all cause mortality or major event · 5 Years
|
10 Participants
|
|
Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention
180 Days - Number of participants with all cause mortality or major event · 5 Years
|
13 Participants
|
|
Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention
1 Year - Number of participants with all cause mortality or major event · 5 Years
|
15 Participants
|
|
Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention
2 Years - Number of participants with all cause mortality or major event · 5 Years
|
19 Participants
|
|
Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention
3 Years - Number of participants with all cause mortality or major event · 5 Years
|
19 Participants
|
|
Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention
4 Years - Number of participants with all cause mortality or major event · 5 Years
|
23 Participants
|
|
Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention
5 Years - Number of participants with all cause mortality or major event · 5 Years
|
23 Participants
|
SECONDARY outcome
Timeframe: 30 days1. All mortality 2. All stroke 3. Residual MR \> mild (1+) 4. Life threatening bleeding 5. Acute kidney injury Grade 3 6. New pacemaker/LBBB 7. Coronary occlusion/myocardial infarction 8. Urgent/emergent surgery or reintervention
Outcome measures
| Measure |
Treatment
n=27 Participants
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
Individual 30 Day Rates of Device and/or Procedure Related Major Adverse Events
Number of participants with a device/procedure related major event within 30 days
|
1 Participants
|
|
Individual 30 Day Rates of Device and/or Procedure Related Major Adverse Events
Number of participants without a device/procedure related major event within 30 days
|
26 Participants
|
SECONDARY outcome
Timeframe: One yearReadmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation
Outcome measures
| Measure |
Treatment
n=27 Participants
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
Number and Percentage of Subjects With Progression of Heart Failure
Number of subjects with progression of heart failure within one year
|
15 Participants
|
|
Number and Percentage of Subjects With Progression of Heart Failure
Number of subjects without progression of heart failure within one year
|
12 Participants
|
SECONDARY outcome
Timeframe: Post procedureMitral regurgitation \< moderate (2+) Effective valve orifice area ≥ 1.5 cm2 as assessed by post-procedural echocardiogram Mitral Valve gradient \< 5 mmHg No migration No fracture No endocarditis Stroke free No additional valve/access related interventional or surgical procedures
Outcome measures
| Measure |
Treatment
n=27 Participants
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter
Number of subjects with technical success
|
24 Participants
|
|
Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter
Number of subjects without technical success
|
3 Participants
|
SECONDARY outcome
Timeframe: At one yearNumber of subjects alive and not hospitalized
Outcome measures
| Measure |
Treatment
n=27 Participants
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
Days Alive and Out of Hospital
|
13 Participants
|
SECONDARY outcome
Timeframe: 30 days, 90 days, 180 days and annually for five yearsPopulation: The number analyzed reduced at each interval due to subjects exiting the trial
Clinical performance as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ). Quality-of-life questionnaire for patients with heart failure. Scores range from 0 to 100: 0-24 is very poor to poor, 25-49 is poor to fair, 50-74 is fair to good, 75-100 is good to excellent.
Outcome measures
| Measure |
Treatment
n=27 Participants
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
Performance - KCCQ
5 Years KCCQ
|
80.0 Scores on a scale
Standard Deviation 13.2
|
|
Performance - KCCQ
30 Days KCCQ
|
48.2 Scores on a scale
Standard Deviation 31.6
|
|
Performance - KCCQ
Baseline KCCQ
|
50.1 Scores on a scale
Standard Deviation 21.3
|
|
Performance - KCCQ
90 Days KCCQ
|
66.5 Scores on a scale
Standard Deviation 25.1
|
|
Performance - KCCQ
180 Days KCCQ
|
71.5 Scores on a scale
Standard Deviation 25.5
|
|
Performance - KCCQ
1 Year KCCQ
|
76.2 Scores on a scale
Standard Deviation 17.1
|
|
Performance - KCCQ
2 Years KCCQ
|
77.9 Scores on a scale
Standard Deviation 11.4
|
|
Performance - KCCQ
3 Years KCCQ
|
79.1 Scores on a scale
Standard Deviation 12.4
|
|
Performance - KCCQ
4 Years KCCQ
|
81.6 Scores on a scale
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: 30 days, 90 days, 180 days and annually for five yearsPopulation: The number analyzed reduced at each interval due to subjects exiting the trial
Clinical performance as measured by New York Heart Association (NYHA) Classification of heart failure. Severity is classified in four classes (I-IV). Class I = mild, no limitation of physical activity. Class II = mild with slight limitation of physical activity. Class III = moderate with marked limitation of physical activity. Class IV = severe with inability to carry out any physical activity without discomfort.
Outcome measures
| Measure |
Treatment
n=27 Participants
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
Performance - NYHA
Baseline NYHA Functional Class
|
3 Scores on a scale
Standard Deviation 0.2
|
|
Performance - NYHA
30 Days NYHA Functional Class
|
2.3 Scores on a scale
Standard Deviation 0.8
|
|
Performance - NYHA
90 Days NYHA Functional Class
|
2.1 Scores on a scale
Standard Deviation 0.7
|
|
Performance - NYHA
180 Days NYHA Functional Class
|
2.0 Scores on a scale
Standard Deviation 0.6
|
|
Performance - NYHA
1 Year NYHA Functional Class
|
1.8 Scores on a scale
Standard Deviation 0.7
|
|
Performance - NYHA
2 Years NYHA Functional Class
|
1.9 Scores on a scale
Standard Deviation 0.6
|
|
Performance - NYHA
3 Years NYHA Functional Class
|
2.1 Scores on a scale
Standard Deviation 0.6
|
|
Performance - NYHA
4 Years NYHA Functional Class
|
2.4 Scores on a scale
Standard Deviation 0.9
|
|
Performance - NYHA
5 Years NYHA Functional Class
|
2.3 Scores on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 30 days, 90 days, 180 days and annually for five yearsPopulation: Number of participants decreases over time due to participants exiting the study or being unable to perform assessment
Clinical performance as measured by 6-Minute Walk Test (6MWT) measures the maximum distance a person can walk along a flat, straight 30 meter course in 6 minutes.
Outcome measures
| Measure |
Treatment
n=27 Participants
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
Performance - 6MWT
2 Year 6MWT distance
|
384.3 Distance in meters
Standard Deviation 68.0
|
|
Performance - 6MWT
3 Years 6MWT distance
|
416.5 Distance in meters
Standard Deviation 4.9
|
|
Performance - 6MWT
4 Years 6MWT distance
|
369.0 Distance in meters
Standard Deviation 1.4
|
|
Performance - 6MWT
5 Years 6MWT distance
|
402.5 Distance in meters
Standard Deviation 31.8
|
|
Performance - 6MWT
Baseline 6MWT distance
|
260.5 Distance in meters
Standard Deviation 114.3
|
|
Performance - 6MWT
30 Days 6MWT distance
|
253.4 Distance in meters
Standard Deviation 151.7
|
|
Performance - 6MWT
90 Days 6MWT distance
|
309.8 Distance in meters
Standard Deviation 134.2
|
|
Performance - 6MWT
180 Days 6MWT distance
|
363.2 Distance in meters
Standard Deviation 108.5
|
|
Performance - 6MWT
1 Year 6MWT distance
|
356.6 Distance in meters
Standard Deviation 91.5
|
Adverse Events
Treatment
Serious events: 23 serious events
Other events: 3 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Treatment
n=27 participants at risk
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
33.3%
9/27 • Number of events 9 • From enrollment to 5 years
|
|
Blood and lymphatic system disorders
Bleeding
|
11.1%
3/27 • Number of events 3 • From enrollment to 5 years
|
|
Nervous system disorders
Stroke/TIA
|
11.1%
3/27 • Number of events 3 • From enrollment to 5 years
|
|
Cardiac disorders
Myocardial Infarction
|
7.4%
2/27 • Number of events 2 • From enrollment to 5 years
|
|
Vascular disorders
Vascular Access Site and Access Related Complications
|
11.1%
3/27 • Number of events 3 • From enrollment to 5 years
|
|
Cardiac disorders
Arrhythmia and Conduction System Disturbances
|
14.8%
4/27 • Number of events 5 • From enrollment to 5 years
|
|
Cardiac disorders
Progression of Heart Failure
|
59.3%
16/27 • Number of events 31 • From enrollment to 5 years
|
|
General disorders
Multi System Organ Failure
|
3.7%
1/27 • Number of events 1 • From enrollment to 5 years
|
Other adverse events
| Measure |
Treatment
n=27 participants at risk
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement
|
|---|---|
|
General disorders
Bleeding (minor)
|
7.4%
2/27 • Number of events 2 • From enrollment to 5 years
|
|
Musculoskeletal and connective tissue disorders
Knee contusion
|
3.7%
1/27 • Number of events 1 • From enrollment to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60