C-Pulse® System European Multicenter Study (OPTIONS HF)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01872949
Recruitment Status : Unknown
Verified March 2016 by CHF Solutions. Recruitment status was: Active, not recruiting
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.
Condition or disease
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
A patient population of up to 50 patients with moderate to severe heart failure refractory to optimal medical therapy, who are implanted with the C-Pulse System as clinically appropriate, will be enrolled into the Study
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
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)