MAVERIC Trial of the ARTO System Encompasses Four Continents and 15 Centres of Excellence
The MAVERIC (MitrAl ValvE RepaIr Clinical) trial program is a prospective, single arm group of studies evaluating the safety and performance of the ARTO System in patients with congestive heart failure associated with mitral regurgitation.
"The ARTO System is a unique solution to treating FMR. The device is safe, the procedure is simple, and the benefit to the patient is almost immediate."
- Simon Redwood, MB, BS, MD, Honorary Consultant Cardiologist and Professor of Interventional Cardiology, St Thomas' Hospital, London, UK
MAVERIC Trial Design
- Major Adverse Event rate* to 30 days
- Reduction of > 1 MR Grade mitral regurgitation at 30 days
- Acute Technical Success (MVARC Definition)
Secondary Outcome Measures
- MAE Rate & MR reduction at 6 Months, 1, 2 and 3 years
- NYHA Class
- Six Minute Walk Test
- Quality of Life
Key Inclusion Criteria
- Refused for MV surgery
- NYHA Class II-IV of any etiology
- Symptomatic with MR grade ≥ 2+
Immediate and Long-Term Maintained Results
31 patients enrolled in the MAVERIC Trial provide evidence that treatment with the ARTO System results in meaningful, immediate and long term MR reduction.
"Ten years ago, I had a heart attack and was treated with a stent. When my condition worsened, I was offered this operation, which made me feel much better. These days, I exercise with my hunting dog: I cycle and he follows me. He is very strong, so have to keep up. And I do!"
- E.L., MAVERIC Trial patient, Latvia