Mitral Valve Regurgitation
Conditions
Keywords
Mitral, Regurgitation, Heart valve, Transcatheter, Transapical, Functional, Degenerative, Symptomatic, severe mitral valve regurgitation, high risk for open mitral valve surgery
Brief summary
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
Detailed description
This is an international, multicenter, single arm, prospective, Early Feasibility Clinical Study to evaluate the safety and performance of the Neovasc Tiara Mitral Valve System in subjects with symptomatic severe mitral regurgitation requiring mitral valve replacement who are at high risk for open chest surgery. A maximum of 30 subjects will be implanted in this study at a maximum of 10 sites. A maximum of 15 subjects will be implanted in the United States. Subjects satisfying the inclusion criteria and exclusion criteria will be enrolled to receive the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Delivery System via a transcatheter mitral valve replacement (TMVR) procedure.
Interventions
DEVICEMitral valve replacement
Transcatheter mitral valve replacement
Sponsors
Shockwave Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Severe symptomatic mitral regurgitation (Stage D) * High surgical risk for open mitral valve surgery * Subject meets the anatomical eligibility criteria for available size(s) * NYHA Class III or IV heart failure
Exclusion criteria
* DMR deemed by the heart team to be operable. * Prohibitive risk, deemed too frail or listed for cardiac transplant. * Unsuitable cardiac structure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From All-cause Mortality and Major Adverse Events | From the time of implant procedure to 30 days or hospital discharge up to 45 days (whichever is later) | Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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, 90 days, 180 days and annually to five years | 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 |
| Individual 30 Day Rates of Device and/or Procedure Related Major Adverse Events | 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 |
| Number and Percentage of Subjects With Progression of Heart Failure | One year | Readmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation |
| Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter | Post procedure | 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 |
| Days Alive and Out of Hospital | At one year | Number of subjects alive and not hospitalized |
| Performance - KCCQ | 30 days, 90 days, 180 days and annually for five years | 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. |
| Performance - NYHA | 30 days, 90 days, 180 days and annually for five years | 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. |
| Performance - 6MWT | 30 days, 90 days, 180 days and annually for five years | 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. |
Countries
Belgium, Canada, United States
Contacts
STUDY_CHAIRAnson Cheung, MD
University of British Columbia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement: Transcatheter mitral valve replacement | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 73.6 years STANDARD_DEVIATION 12.1 |
| Cardiomyopathy | 16 Participants |
| Chronic Lung Disease | 10 Participants |
| Diabetes | 8 Participants |
| Ejection Fraction | 39 Percentage STANDARD_DEVIATION 8.3 |
| Heart Failure | 27 Participants |
| Hypertension | 22 Participants |
| Mitral Regurgitation Severity Moderate-Severe | 1 Participants |
| Mitral Regurgitation Severity Severe | 26 Participants |
| NYHA Functional Class NYHA Functional Class I | 0 participants |
| NYHA Functional Class NYHA Functional Class II | 0 participants |
| NYHA Functional Class NYHA Functional Class III | 26 participants |
| NYHA Functional Class NYHA Functional Class IV | 1 participants |
| Obstructive Coronary Artery Disease | 18 Participants |
| Peripheral Vascular Disease | 6 Participants |
| Predicted Surgical Mortality | 7.4 Probability Percentage STANDARD_DEVIATION 3.7 |
| Previous Clinically Significant Arrhythmia | 23 Participants |
| Previous Coronary Artery Bypass | 9 Participants |
| Previous Myocardial Infarction | 12 Participants |
| Previous Percutaneous Coronary Intervention | 11 Participants |
| Previous Valve Replacement or Repair | 7 Participants |
| Prior Pacemaker/ICD/CRT | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment Belgium | 5 participants |
| Region of Enrollment Canada | 18 participants |
| Region of Enrollment United States | 4 participants |
| Renal Dysfunction | 14 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 20 / 27 |
| other Total, other adverse events | 3 / 27 |
| serious Total, serious adverse events | 23 / 27 |
Outcome results
Primary
Freedom From All-cause Mortality and Major Adverse Events
Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Freedom From All-cause Mortality and Major Adverse Events | 19 Participants |
Secondary
Days Alive and Out of Hospital
Number of days alive and not hospitalized
Time frame: At one year
Secondary
Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter
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
Time frame: Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years
Secondary
Individual 30 Day Rates of Device and Procedure Related Major Adverse Events
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
Time frame: 30 days
Secondary
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
Time frame: 30 days, 90 days, 180 days and annually to five years
Secondary
Number and Percentage of Subjects With Progression of Heart Failure
Readmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation
Time frame: One year
Secondary
Performance
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
Time frame: 30 days, 90 days, 180 days and annually for five years