Mitral Valve Regurgitation (Degenerative or Functional)
Conditions
Brief summary
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
Detailed description
The study is a multi-center, First-In-Human, prospective, single pilot study to evaluate the safety and performance of the Innovalve mitral valve replacement system
Interventions
DEVICEInnovalve MR system
Innovalve MR 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 | Description |
|---|---|---|
| Procedural success | 30 days | All of the following must be present: I. Deployment of the device II. Absence of major device or procedure related serious adverse events, including: 1. Death 2. Stroke 3. Life-threatening bleeding (MVARC scale) 4. Major vascular complications 5. Major cardiac structural complications 6. Stage 2 or 3 acute kidney injury (includes new dialysis) 7. Myocardial infarction or coronary ischemia requiring PCI or CABG 8. Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for 48 h. 9. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention |
| NYHA functional class | 30 days, 6, 1 year | — |
| Technical success | Procedure | i. Absence of procedural mortality; and ii. Successful access, delivery, and retrieval of the device delivery system; and iii. Successful deployment and correct positioning of the first intended device; and iv. Freedom from emergency surgery or reintervention related to the device or access procedure. |
| Quality of life improvement (KCCQ-12) Kansas City Cardiomyopathy Questionnaire | 30 days, 6, 1 year | — |
| Reduction in Mitral Regurgitation grade | 30 days, 6, 1 year | — |
| Six-minute walk test | 30 days, 6, 1 year | — |
Countries
Georgia
Outcome results
None listed