C-Pulse® System European Multicenter Study

Completed

Conditions: Heart Failure

Registration Number: NCT01872949

Lead Sponsor: Nuwellis, Inc.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

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)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival and Study Completion	5 years	Amount of participants that did not exit study for reasons including worsening heart failure resulting in hospitalization, LVAD implantation, study withdrawal or death.
KCCQ	6 months	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.
Six Minute Walk Test	6 months	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.
INTERMACS Subject Profile/Status	6 months	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
NYHA Classification	6 Months	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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (8): Unfallkrankenhaus
🇩🇪
Berlin, Germany
Universität Tübingen
🇩🇪
Tübingen, Germany
Cardio-Centrum Berlin
🇩🇪
Berlin, Germany
Vivantes Klinikum
🇩🇪
Berlin, Germany
Universitätsklinikum Erlangen
🇩🇪
Erlangen, Germany
Evangelisches Krankenhaus Niederrhein
🇩🇪
Duisburg, Northrhine-Westfalia, Germany
Medizinische Hochschule
🇩🇪
Hannover, Germany
University Hospital
🇦🇹
Innsbruck, Austria