Heart Failure, Mitral Regurgitation
Conditions
Keywords
heart failure, mitral regurgitation
Brief summary
Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.
Interventions
Percutaneous access from right or left subclavian vein with placement of assessment and placement of PTMA Implant into the coronary sinus, great cardiac vein. Device remains accessible from a subclavicular pocket.
Sponsors
Viacor
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* symptomatic heart failure * moderate to severe mitral regurgitation * 20 - 50% LVEF
Exclusion criteria
* mitral regurgitation of organic origins * recent interventions * severe comorbidities
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 of mitral annulus anterior posterior dimension | 30 days |
| improvement of clinical symptoms of heart failure as defined by percent of patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in exercise capacity: 6 minute walk or VO2max | 30 days |
Countries
Germany
Outcome results
None listed