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OPTIONS HF: C-Pulse® System European Multicenter Study

Sponsor
Nuwellis, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01872949
Collaborator
(none)
50
Enrollment
14
Locations
67
Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated 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 1, 2013
    Anticipated Primary Completion Date :
    Dec 1, 2018
    Anticipated Study Completion Date :
    Dec 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Freedom from worsening heart failure resulting in hospitalization, LVAD implantation, or death [12 Months]

    2. All Protocol Defined Adverse Events [12 Months]

    Secondary Outcome Measures

    1. Improvement in LVEF, QOL Scores and 6MHW [6 and 12 Months]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Allgemeines Krankenhaus Vienna Wien Austria 1090
    2 University Hospital Innsbruck Austria 6020
    3 Evangelisches Krankenhaus Niederrhein Duisburg Northrhine-Westfalia Germany 47169
    4 Cardio-Centrum Berlin Berlin Germany 10117
    5 Campus Benjamin Franklin Berlin Germany 12203
    6 Deutsches Herzzentrum Berlin Berlin Germany 13353
    7 Vivantes Klinikum Berlin Germany 13407
    8 Unfallkrankenhaus Berlin Germany
    9 Universitätsklinikum Erlangen Erlangen Germany 91054
    10 Hamburg CardioClinic Hamburg Germany 20259
    11 Medizinische Hochschule Hannover Germany
    12 Universität Tübingen Tübingen Germany 72076
    13 Golden Jubilee Hospital Glascow Dunbartonshire United Kingdom G81 4DY
    14 Royal Brompton & Harefield Harefield Middlesex United Kingdom UB96JH

    Sponsors and Collaborators

    • Nuwellis, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nuwellis, Inc.
    ClinicalTrials.gov Identifier:
    NCT01872949
    Other Study ID Numbers:
    • PRO 04654-C
    First Posted:
    Jun 7, 2013
    Last Update Posted:
    Mar 7, 2016
    Last Verified:
    Mar 1, 2016
    Keywords provided by Nuwellis, Inc.
    Heart Failure
    NYHA Class III
    NYHA Class IV
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Mar 7, 2016