The ContraBand™ device is intended for treatment of heart failure patients
who remain symptomatic despite the use of optimally tolerated guideline directed medical therapy.
Sponsor
Study objectives
This study is intended to evaluate the safety and feasibility of the
ContraBand™ system in the treatment of chronic LV heart failure patients who remain symptomatic despite stable, optimal heart failure medical therapy.
Primary endpoints
Safety endpoints:
Device-related or procedure -related major adverse events (MAEs) within 30 days.
MAE is a composite of death, myocardial infarction, emergent conversion to surgery, stroke, major cardiac structure complication, major vascular complication, embolization and heart failure -related hospitalization.
Performance endpoints:
Procedural success (device delivered and deployed in the Pulmonary Arteries) -post implantation.
CERC Services
- CoreLab activities
Countries
Belgium, Czech, Republic Georgia, Germany, Israel, Lithuania, Poland
Number of investigational sites
15
