C-Pulse® System European Multicenter Study
C-Pulse® System European Multicenter Study
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)