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

October 26, 2015 updated by: Finn Gustafsson, Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Kbh Oe
      • Copenhagen, Kbh Oe, Denmark, 2100
        • University Hospital Rigshospitalet.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All heart failure patients with CF-LVAD at University Hospital of Copenhagen, Rigshospitalet.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CF-LVAD pump speed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary capillary wedge pressure in mmHg.
Time Frame: On trial day.
On trial day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimate)

May 13, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2013-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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