Heart Failure, Mitral Regurgitation
Conditions
Keywords
Heart Failure, Mitral Regurgitation
Brief summary
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device
Interventions
DEVICEPTMA Implant
Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein.
Sponsors
Viacor
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic heart failure * functional MR 2+ - 4+ * LVEF 20% - 50%
Exclusion criteria
* MR of organic origins * significant co-morbidities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percent of patients who remain free from device-related major adverse events: death, myocardial infarction, tamponade, emergent cardiac surgery | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction in mitral anterior posterior dimension | 30 days |
| improvement of clinical symptoms of heart failure as defined by percent of implanted patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in 6 minute walk, improvement in VO2 max. | 30 days |
Countries
Germany
Outcome results
None listed