Mitral Valve Regurgitation
Conditions
Keywords
Mitral, Regurgitation, Heart valve, Transcatheter, Transapical, Functional, Degenerative, TMVR
Brief summary
To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
Detailed description
The TIARA-II study is an international, multicenter, single-arm, prospective, safety and performance clinical study.
Interventions
DEVICETIARA valve and transapical delivery system
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 mitral regurgitation * High surgical risk for open mitral valve surgery * Subject meets anatomical eligibility criteria
Exclusion criteria
* Deemed too frail by objective frailty assessments * Previous cardiac procedures: any mitral valve replacement surgery and cardiac transplant * Unsuitable cardiac structure * Clinically significant untreated Coronary Artery Disease (CAD) * Subjects on chronic dialysis * Pregnant or planning pregnancy within next 12 months * Documented bleeding or coagulation disorders * Active infections requiring antibiotic therapy * Subjects with a life expectancy less than 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from all-cause mortality | 30 days |
| Freedom from major adverse events | 30 Days |
| Reduction of Mitral Regurgitation to optimal or acceptable | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | 30 days | Per MVARC criteria |
| Device success | Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years | Per MVARC criteria |
| NYHA Functional Class | 30 days, 90 days, 180 days and once annually for five years | Number of subjects with improved NYHA class |
| Freedom from all-cause mortality | 90 days, 180 days, one year and annually to five years | — |
| Kansas City Cardiomyopathy Questionnaire | 30 days, 90 days, 180 days and once annually for five years | Improvement in quality of life |
| Hemodynamic performance | 30 days, 90 days, 180 days and once annually for five years | Assessed by echocardiography |
| Patient success | 1 year | Per MVARC Criteria |
| 6 Minute Walk Test | 30 days, 90 days, 180 days and once annually for five years | Increase in distance (m) from baseline |
| Freedom from major adverse events | 90 days, 180 days, one year and annually to five years | — |
| Technical success | Day 0 | Per MVARC criteria |
Countries
Germany, Israel, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed