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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

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ClinicalTrials.gov Identifier: NCT01851889
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Finn Gustafsson, Rigshospitalet, Denmark

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
Heart Failure.

Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : April 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort
CF-LVAD pump speed.



Primary Outcome Measures :
  1. Pulmonary capillary wedge pressure in mmHg. [ Time Frame: On trial day. ]


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:   Probability Sample
Study Population
All heart failure patients with CF-LVAD at University Hospital of Copenhagen, Rigshospitalet.
Criteria

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.

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): NCT01851889


Locations
Denmark
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.

Responsible Party: Finn Gustafsson, DMSc, Ph.d., Chief Physician., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01851889     History of Changes
Other Study ID Numbers: H-3-2013-010
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases