Clinical trial NCT01872949: C-Pulse® System European Multicenter Study
Official title: C-Pulse System eurOPean mulTicenter Study, Implantable cOuNterpulsation System in patIents With Moderate to Severe Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
NYHA Class III
NYHA Class IV
Lead sponsor: Nuwellis, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Survival and Study Completion
timeFrame: 5 years
measure: NYHA Classification
timeFrame: 6 Months
measure: INTERMACS Subject Profile/Status
timeFrame: 6 months
measure: Six Minute Walk Test
timeFrame: 6 months
measure: KCCQ
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: University Hospital
city: Duisburg
country: Germany
facility: Evangelisches Krankenhaus Niederrhein
state: Northrhine-Westfalia
city: Berlin
country: Germany
facility: Cardio-Centrum Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum
city: Berlin
country: Germany
facility: Unfallkrankenhaus
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Hannover
country: Germany
facility: Medizinische Hochschule
city: Tübingen
country: Germany
facility: Universität Tübingen
Study officials:
References:
citation: 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.