Heart Failure, Mitral Regurgitation
Conditions
Keywords
Heart Failure, Mitral Regurgitation
Brief summary
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.
Interventions
Percutaneous access from right or left subclavian vein, diagnostic assessment, then placement of the 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
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Functional MR 2+ - 4+ with left ventricular enlargement * Symptomatic heart failure * 20% - 50% LVEF
Exclusion criteria
* mitral regurgitation of organic origins * recent cardiac 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 MR and reduction of mitral annulus anterior posterior dimension | 30 days |
| percent of implanted patients who exhibit improvement of clinical symptoms as one of the following: decrease in NYHA class, improvement of Minnesota QOL survey, increase exercise capacity 6 minute walk or improvement in VO2 max | 30 days |
Countries
Canada
Outcome results
None listed