Mitral Valve Regurgitation (Degenerative or Functional)
Conditions
Brief summary
Study to evaluate the safety and performance of the INNOVALVE system
Detailed description
The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the INNOVALVE system
Interventions
DEVICEINNOVALVE system
INNOVALVE system
Sponsors
Edwards Lifesciences
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
* Clinically significant, symptomatic mitral regurgitation * High risk for open-heart surgery * Meets anatomical criteria
Exclusion criteria
* Unsuitable anatomy * Patient is inoperable * EF\<25%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of implant or delivery related serious adverse events at 30 Days | 30 days | Absence of implant or delivery related serious adverse events |
Secondary
| Measure | Time frame |
|---|---|
| Technical success | Procedure |
| Procedural success | 30 days |
| NYHA functional class | 30 days, 6, 12 months and annually up to 5 years |
| Six-minute walk test | 30 days, 6, 12 months and annually up to 5 years |
| Quality of life improvement (KCCQ-12) | 30 days, 6, 12 months and annually up to 5 years |
| Reduction in MR grade | 30 days, 6, 12 months and annually up to 5 years |
Countries
United States
Contacts
CONTACTTMTT Clinical
PRINCIPAL_INVESTIGATORChet Rihal
Mayo Clinic
Outcome results
None listed