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Optimizing Continuous-flow Left Ventricular Assist Device Settings and Identification of Pump Malfunction - A Comparative Study of Echocardiography and Invasive Hemodynamics

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT01851889
Collaborator
(none)
15
Enrollment
1
Location
30
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the trial is to identify factors which can be used as guidance when optimizing continuous-flow left ventricular assist device (CF-LVAD) settings.

The hypothesis of the study is that pulmonary capillary wedge pressure (PCWP) will change independently of left ventricular end diastolic diameter (LVEDD) when increasing pump speed ie ΔPCWP/RPM ≠ ΔLVEDD/RPM.

The primary combined endpoint of the study is correlation between ΔPCWP and LVEDD slope under ramp testing in a cohort of "continuous-flow left ventricular assist device" heart failure patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    15 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Apr 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Oct 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    CF-LVAD pump speed.

    Outcome Measures

    Primary Outcome Measures

    1. Pulmonary capillary wedge pressure in mmHg. [On trial day.]

    Eligibility Criteria

    Criteria

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

    • Heart failure patients with HeartMate II (HM II) followed as outpatients at The Heart Centre at University Hospital of Copenhagen, Rigshospitalet.

    • Age > 18 years.

    • Heart failure in stable phase without the need for intravenous inotropic therapy.

    • Ischemic or non-ischemic cardiomyopathy.

    • Signed informed consent.

    Exclusion Criteria:

    • Unstable patients with the need for intravenous inotropic therapy.

    • Current hospitalization.

    • Implantation of HM II less than one month ago.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Rigshospitalet. Copenhagen Kbh Oe Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    • Principal Investigator: Mette H Jung, MD, Department of Cardiology B, University Hospital Rigshospitalet.
    • Principal Investigator: Finn Gustafsson, MD, DMSc, PhD, Department of Cardiology B, University Hospital Rigshospitalet.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Finn Gustafsson, DMSc, Ph.d., Chief Physician., Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT01851889
    Other Study ID Numbers:
    • H-3-2013-010
    First Posted:
    May 13, 2013
    Last Update Posted:
    Oct 28, 2015
    Last Verified:
    Oct 1, 2015
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Oct 28, 2015