C-Pulse® System European Multicenter Study

C-Pulse System eurOPean mulTicenter Study, Implantable cOuNterpulsation System in patIents With Moderate to Severe Heart Failure

The study is designed to observe the clinical outcomes of heart failure patients treated with C-Pulse® System in the usual manner and according to the approved indications and contraindications.

Evaluation of the post-market clinical performance and safety of the C-Pulse® System for the treatment of Heart Failure in the population of patients who meet the approved clinical conditions provided in the indications and contraindications.

Inclusion Criteria:

• Patient is 18 years or older
• Patients with moderate to severe ambulatory heart failure [American College of Cardiology/American Heart Association (ACC/AHA) Stage C; NYHA Class III/IV ambulatory], who are refractory to optimal medical therapy
• Patients who are non-responders to CRT pacemaker therapy
• Patient has signed and dated the investigation informed consent form

Exclusion Criteria:

• Evidence of significant ascending aortic calcification on postero-anterior chest X-ray or CT scan
• Moderate or severe atherosclerotic aortic disease
• Ascending aorto-coronary artery bypass grafts
• Any history of aortic dissection
• Connective tissue disorder such as Marfans disease
• Aorta not conforming to specified dimensional constraints
• Patient has severe mitral valve incompetence, grade 4+
• Patient has moderate to severe aortic valve incompetence, grade 2 - 4+
• Patient has systolic blood pressure less than 90 or greater than 140mmHg
• Presence of active systemic infection
• Presence of bleeding or coagulation disorder (relative)