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C-Pulse® System European Multicenter Study (OPTIONS HF)

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ClinicalTrials.gov Identifier: NCT01872949
Recruitment Status : Unknown
Verified March 2016 by CHF Solutions.
Recruitment status was:  Active, not recruiting
First Posted : June 7, 2013
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
CHF Solutions

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.

Condition or disease
Heart Failure

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: C-Pulse System eurOPean mulTicenter Study, Implantable cOuNterpulsation System in patIents With Moderate to Severe Heart Failure
Study Start Date : May 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. Freedom from worsening heart failure resulting in hospitalization, LVAD implantation, or death [ Time Frame: 12 Months ]
  2. All Protocol Defined Adverse Events [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Improvement in LVEF, QOL Scores and 6MHW [ Time Frame: 6 and 12 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872949


Locations
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Austria
Allgemeines Krankenhaus
Vienna, Wien, Austria, 1090
University Hospital
Innsbruck, Austria, 6020
Germany
Evangelisches Krankenhaus Niederrhein
Duisburg, Northrhine-Westfalia, Germany, 47169
Cardio-Centrum Berlin
Berlin, Germany, 10117
Campus Benjamin Franklin
Berlin, Germany, 12203
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Vivantes Klinikum
Berlin, Germany, 13407
Unfallkrankenhaus
Berlin, Germany
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Hamburg CardioClinic
Hamburg, Germany, 20259
Medizinische Hochschule
Hannover, Germany
Universität Tübingen
Tübingen, Germany, 72076
United Kingdom
Golden Jubilee Hospital
Glascow, Dunbartonshire, United Kingdom, G81 4DY
Royal Brompton & Harefield
Harefield, Middlesex, United Kingdom, UB96JH
Sponsors and Collaborators
CHF Solutions

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CHF Solutions
ClinicalTrials.gov Identifier: NCT01872949     History of Changes
Other Study ID Numbers: PRO 04654-C
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: March 7, 2016
Last Verified: March 2016

Keywords provided by CHF Solutions:
Heart Failure
NYHA Class III
NYHA Class IV

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases