C-Pulse® System European Multicenter Study (OPTIONS-HF)

Nuwellis

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT01872949

PRO 04654-C

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design