Trial Outcomes & Findings for Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System (NCT NCT02276547)

NCT ID: NCT02276547

Last Updated: 2025-05-20

Results Overview

Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: From the time of implant procedure to 30 days or hospital discharge (whichever is later)
• Results posted on: 2025-05-20

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	23
Overall Study NOT COMPLETED	4

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	2
Overall Study Explant	2

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 (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 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

1. 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

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Readmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years

Mitral 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

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 90 days, 180 days and annually for five years

Clinical performance as measured by NYHA Functional Class, 6MWT, and the KCCQ Hemodynamic performance as assessed by echocardiography: mean MV gradient, mitral regurgitation, effective orifice area of the MV, LV systolic and diastolic dimensions as well as volume Stroke free survival Original intended device in place No additional valve/access-related interventional or surgical procedures

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At one year

Number of days alive and not hospitalized

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 19 serious events

Other events: 6 other events

Deaths: 3 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	29.6% 8/27 • Number of events 8 • 30 days
Blood and lymphatic system disorders Bleeding	11.1% 3/27 • Number of events 3 • 30 days
Nervous system disorders Stroke/TIA	7.4% 2/27 • Number of events 2 • 30 days
Cardiac disorders Myocardial Infarction	7.4% 2/27 • Number of events 2 • 30 days
Vascular disorders Vascular Access Site and Access Related Complications	7.4% 2/27 • Number of events 2 • 30 days
Cardiac disorders Arrhythmia and Conduction System Disturbances	7.4% 2/27 • Number of events 2 • 30 days
Cardiac disorders Progression of Heart Failure	37.0% 10/27 • Number of events 11 • 30 days
Cardiac disorders Decreased Ejection Fraction	3.7% 1/27 • Number of events 1 • 30 days
Infections and infestations Infection - Not related to Study Device/Procedure	18.5% 5/27 • Number of events 6 • 30 days
Cardiac disorders Mitral Regurgitation	3.7% 1/27 • Number of events 1 • 30 days
General disorders Multi System Organ Failure	3.7% 1/27 • Number of events 1 • 30 days
Respiratory, thoracic and mediastinal disorders Pleural Effusion	3.7% 1/27 • Number of events 1 • 30 days
Blood and lymphatic system disorders Thrombocytopenia	3.7% 1/27 • Number of events 1 • 30 days
Cardiac disorders Valve Migration	7.4% 2/27 • Number of events 2 • 30 days

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
Gastrointestinal disorders Constipation	3.7% 1/27 • Number of events 1 • 30 days
Eye disorders Eye Infection	3.7% 1/27 • Number of events 1 • 30 days
Cardiac disorders Myocardial Infarction	3.7% 1/27 • Number of events 1 • 30 days
Nervous system disorders Pre Syncope	3.7% 1/27 • Number of events 1 • 30 days
Respiratory, thoracic and mediastinal disorders Pleural Effusion	7.4% 2/27 • Number of events 2 • 30 days
Respiratory, thoracic and mediastinal disorders Atelectasis	3.7% 1/27 • Number of events 1 • 30 days

Additional Information

Lisa Read, Clinical Study Manager

Neovasc

Phone: 8558025180

Email: lread@neovasc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60