C-Pulse® System European Multicenter Study

NCT01872949 | Completed Results

• 1 other identifier: PRO 04654-C
• Study Type: observational
• Target: 15
• Locations: 2 countries
• Sites: 8

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.

Conditions

Heart Failure

Keywords

Heart Failure; NYHA Class III; NYHA Class IV

Outcome Measures

Primary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nuwellis, Inc.: lead

Study Sites (8)

University Hospital

Innsbruck, 6020, Austria

Location

Evangelisches Krankenhaus Niederrhein

Duisburg, Northrhine-Westfalia, 47169, Germany

Location

Cardio-Centrum Berlin

Berlin, 10117, Germany

Location

Vivantes Klinikum

Berlin, 10249, Germany

Location

Unfallkrankenhaus

Berlin, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Medizinische Hochschule

Hanover, Germany

Location

Universität Tübingen

Tübingen, 72076, Germany

Location

Related Publications (1)

• Schulz A, Krabatsch T, Schmitto JD, Hetzer R, Seidel M, Dohmen PM, Hotz H. Preliminary Results From the C-Pulse OPTIONS HF European Multicenter Post-Market Study. Med Sci Monit Basic Res. 2016 Feb 18;22:14-9. doi: 10.12659/MSMBR.896959.

  PMID: 26887528 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Audrey Singh
• Organization: CHF Solutions, Inc.

audrey.singh@chf-solutions.com

952-345-4217

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 7, 2013
• Study Start: January 13, 2014
• Primary Completion: May 7, 2018
• Study Completion: June 21, 2018
• Last Updated: August 8, 2023
• Results First Posted: August 8, 2023

Record last verified: 2023-08

Locations

AU (1); DE (7)