C-Pulse® System European Multicenter Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival and Study Completion | Amount of participants that did not exit study for reasons including worsening heart failure resulting in hospitalization, LVAD implantation, study withdrawal or death. | 5 years | 
| NYHA Classification | Participant NYHA Classification at 6 month follow up. The NYHA Classification involved 4 classes. I No limitation of physical activity II Slight limitation of physical activity III Marked limitation of physical activity IV Unable to carry on any physical activity without discomfort | 6 Months | 
| INTERMACS Subject Profile/Status | 1. Critical Cardiogenic Shock, 2. Progressive Decline, 3. Stable but Inotrope Dependent, 4. Resting Symptoms, 5. Exertion Intolerant, 6. Exertion Limited, 7. Advanced NYHA Class III, 8. NA/NYHA class I or II | 6 months | 
| Six Minute Walk Test | The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. | 6 months | 
| KCCQ | Overall score from Kansas City Cardiomyopathy Questionnaire, a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status,which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. Scores range from 0-100, in which higher scores reflect better health status. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, NYHA Class III, NYHA Class IV