C-Pulse® System European Multicenter Study

Nuwellis, Inc.15 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (8)

University Hospital

Innsbruck, Austria

Evangelisches Krankenhaus Niederrhein

Duisburg, Northrhine-Westfalia, Germany

Cardio-Centrum Berlin

Berlin, Germany

Vivantes Klinikum

Berlin, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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